Instrumentation Laboratory Co.

Entity profile compiled from public source records

Public Record Profile Registrations: 3 510(k) filings: 50 Recalls: 50

Known Identifiers & Locations

FEI Numbers 1217183, 2431530, 3037000637
Owner Operator Numbers 1217183
Locations Covered Bedford, MA, US; Devens, MA, US; ORANGEBURG, NY, US

Registered Establishments (3)

Registration # Establishment Name Location Establishment Type(s) Action
1217183 INSTRUMENTATION LABORATORY CO. Bedford, MA, US Complaint File Establishment per 21 CFR 820.198 View Details
2431530 INSTRUMENTATION LABORATORY CO. ORANGEBURG, NY, US Manufacture Medical Device View Details
3037000637 INSTRUMENTATION LABORATORY CO. - Devens Devens, MA, US Repack or Relabel Medical Device View Details

510(k) Premarket Notifications (50)

Submission # Device Name Decision Date Decision Description Action
K010379 IL TEST FREE PROTEIN S 2001-04-13 Substantially Equivalent View Details
K021022 HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) 2002-05-14 Substantially Equivalent View Details
K033631 MODIFICATION TO COATEST FACTOR VIII 2003-12-15 Substantially Equivalent View Details
K041905 HEMOSIL CALIBRATION PLASMA 2004-09-28 Substantially Equivalent View Details
K042576 COATEST SP FVIII 2004-12-02 Substantially Equivalent View Details
K043459 HEMOSIL FACTOR XII DEFICIENT PLASMA 2005-02-09 Substantially Equivalent View Details
K061598 HEMOSIL HOMOCYSTEINE AND CONTROLS 2006-09-22 Substantially Equivalent View Details
K070005 HEMOSIL RECOMBIPLASTIN 2G 2007-08-15 Substantially Equivalent View Details
K082859 HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED 2008-12-19 Substantially Equivalent View Details
K091556 HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS 2010-05-21 Substantially Equivalent View Details
K113211 HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL 2012-01-04 Substantially Equivalent View Details
K151534 HemosIL D-Dimer HS 2015-07-06 Substantially Equivalent View Details
K160885 HemosIL D-Dimer HS 2016-10-27 Substantially Equivalent View Details
K180486 HemosIL Factor XII Deficient Plasma 2018-03-22 Substantially Equivalent View Details
K183555 GEM Premier ChemSTAT 2019-02-16 Substantially Equivalent View Details
K760208 OXIMETER, CO-, IL MODEL 282 1976-07-26 Substantially Equivalent View Details
K760211 ANALYZER, GLUCOSE/UREA/CREATININE 1976-08-26 Substantially Equivalent View Details
K760232 PRINTER, IL 460 1976-08-26 Substantially Equivalent View Details
K760969 PH/BLOOD GAS SYSTEM 1977-01-12 Substantially Equivalent View Details
K770946 RECORD, MODEL 702, I.L. 1977-07-05 Substantially Equivalent View Details
K771337 I.L. MODEL 643 FLAME PHOTOMETER 1977-10-18 Substantially Equivalent View Details
K771441 MULTISTAT III CPK TEST 1977-08-22 Substantially Equivalent View Details
K771442 MULTISTAT III UREA NITROGEN TEST 1977-08-22 Substantially Equivalent View Details
K771464 MULTISTAT III GLUCOSE TEST 1977-09-02 Substantially Equivalent View Details
K771467 MULTISTAT III ASPARTATE AMINOTRANSFERASE 1977-09-02 Substantially Equivalent View Details
K771476 MULTISTAT III TOTAL PROTEIN TEST 1977-09-12 Substantially Equivalent View Details
K771508 MULTISTAT III CHOLESTEROL TEST 1977-09-13 Substantially Equivalent View Details
K771977 CARDIAC OUTPUT COMPUTER MODEL 701 1978-01-03 Substantially Equivalent View Details
K781173 COMPUTER INTERFACE IL 814 1978-09-14 Substantially Equivalent View Details
K801007 IL SYSTEM 502 NA/K ANALYZER 1980-05-14 Substantially Equivalent View Details
K812750 IL 703, STAT SEPARATOR 1982-01-26 Substantially Equivalent View Details
K820744 IL MODEL 1301, PH BLOOD GAS SYSTEM 1982-04-15 Substantially Equivalent View Details
K833836 IL HEPARINIZED FLOW DIRECTED THERMAL 1984-02-04 Substantially Equivalent View Details
K884771 IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY 1989-02-10 Substantially Equivalent View Details
K912711 IL TEST PROCLOT ASSAY STYSTEM 1991-10-09 Substantially Equivalent View Details
K913738 IL TEST(TM) AMPHETAMINE 1991-11-07 Substantially Equivalent View Details
K913740 IL TEST(TM) DAT CAL/CONTROL SET B 1991-10-21 Substantially Equivalent View Details
K914151 IL TEST(TM DIGOXIN 1991-11-29 Substantially Equivalent View Details
K914877 IL TEST(TM) UREA NITROGEN 1992-03-11 Substantially Equivalent View Details
K920417 IL TEST BARBITURATE, 35289 1992-04-24 Substantially Equivalent View Details
K920418 IL TEST CANNABINOID, 35282 1992-02-27 Substantially Equivalent View Details
K924884 IL TEST(TM) PRO-CHROM 1993-01-14 Substantially Equivalent View Details
K930327 IL TEST(TM) PROTEIN S 1993-04-12 Substantially Equivalent View Details
K931117 ASSESS(TM) LOW ABNORMAL CONTROL 1994-03-30 Substantially Equivalent View Details
K931362 IL TEST CALCIUM 1994-02-01 Substantially Equivalent View Details
K933252 IL TEST (TM) PT-FIBRINOGEN HS PLUS 1993-10-04 Substantially Equivalent View Details
K961991 ACL 6000 SYSTEM (ACL 6000) 1996-09-04 Substantially Equivalent View Details
K971777 QUANTEX ASO-CRP-RF CONTROL 1997-05-27 Substantially Equivalent View Details
K980242 IL TEST HEPARIN 1998-03-19 Substantially Equivalent View Details
K980646 IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES 1998-05-06 Substantially Equivalent View Details

FDA Recall History (50)

Recall # Product Description Initiation Date Status Action
Z-0027-04 Lactate Disposable Membrane Caps Product Number: 0018108400 Reason: Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L. 2003-08-28 Terminated View Details
Z-0077-2019 Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy. Reason: There is a potential for increased imprecision, out of range quality controls and prolonged sample results. 2018-08-01 Terminated View Details
Z-0135-2011 ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Reason: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves 2010-08-13 Terminated View Details
Z-0136-2011 ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves 2010-08-13 Terminated View Details
Z-0137-2011 ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves 2010-08-13 Terminated View Details
Z-0138-2011 ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves 2010-08-13 Terminated View Details
Z-0378-06 GEM PREMIER 3000 Reason: Software error may report higher results for glucose and lactate 2005-12-16 Terminated View Details
Z-0514-2014 HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval 2013-11-15 Terminated View Details
Z-0515-2014 HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval 2013-11-15 Terminated View Details
Z-0516-2014 HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval 2013-11-15 Terminated View Details
Z-0736-04 ACL Futura Instrument Analyzer Reason: Software may cause instrument to omit step causing reagent carrover which may effect patient test result 2004-03-04 Terminated View Details
Z-0736-2016 HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate Reason: This Lot is not meeting labeled on-board instrument stability claims of 5 days. 2015-12-18 Terminated View Details
Z-0737-04 ACL Advance Instrument Analyzer Reason: Software may cause instrument to omit step causing reagent carrover which may effect patient test result 2004-03-04 Terminated View Details
Z-0778-2007 GEM Premier 4000 Laboratory Analyzer Reason: Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result 2007-03-27 Terminated View Details
Z-0803-2011 ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing. Reason: Sporadically lowered APTT results were observed with the PT/APTT Test Groups. 2010-11-11 Terminated View Details
Z-0804-2011 ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing. Reason: Sporadically lowered APTT results were observed with the PT/APTT Test Groups. 2010-11-11 Terminated View Details
Z-0805-2011 ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing. Reason: Sporadically lowered APTT results were observed with the PT/APTT Test Groups. 2010-11-11 Terminated View Details
Z-0806-2011 ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing. Reason: Sporadically lowered APTT results were observed with the PT/APTT Test Groups. 2010-11-11 Terminated View Details
Z-0807-2011 ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing. Reason: Sporadically lowered APTT results were observed with the PT/APTT Test Groups. 2010-11-11 Terminated View Details
Z-0832-2015 HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT). Reason: Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times. 2014-11-21 Terminated View Details
Z-0845-03 GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use Reason: Incorrect bar code applied to cartridges could result in inaccurate pO2 value 2003-03-07 Terminated View Details
Z-0846-03 GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use Reason: Incorrect bar code applied to cartridges could result in inaccurate pO2 value 2003-03-07 Terminated View Details
Z-0895-2018 Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 Reason: Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results. 2017-08-02 Terminated View Details
Z-0915-05 ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent Reason: Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy 2005-05-19 Terminated View Details
Z-1127-2007 Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000 Reason: ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube. 2007-06-19 Terminated View Details
Z-1246-06 HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer; and RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative. --- FOR IN VITRO DIAGNOSTIC USE. Reason: Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection). 2006-03-07 Terminated View Details
Z-1247-06 Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in reagent purity, ISI values and performance from lot to lot. Once reconstituted, it is ready for use in the one-stage PT test. Hemoliance RecombiPlasTin Diluent is an aqueous solution of calcium chloride and a preservative. --- FOR IN VITRO DIAGNOSTIC USE. Reason: Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection). 2006-03-07 Terminated View Details
Z-1519-2012 Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems Reason: Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay. 2012-04-11 Terminated View Details
Z-1784-2013 HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy. Reason: Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification. 2013-04-09 Terminated View Details
Z-2060-2014 ACL TOP (Base), automated coagulation laboratory instrument. Reason: Potential for sample misidentification. 2014-06-03 Terminated View Details
Z-2061-2014 ACL TOP 700, automated coagulation laboratory instrument. Reason: Potential for sample misidentification. 2014-06-03 Terminated View Details
Z-2062-2014 ACL TOP CTS, automated coagulation laboratory instrument. Reason: Potential for sample misidentification. 2014-06-03 Terminated View Details
Z-2063-2014 ACL TOP 700 LAS, automated coagulation laboratory instrument. Reason: Potential for sample misidentification. 2014-06-03 Terminated View Details
Z-2064-2014 ACL TOP 500 CTS, automated coagulation laboratory instrument. Reason: Potential for sample misidentification. 2014-06-03 Terminated View Details
Z-2065-2014 ACL TOP 700 CTS, automated coagulation laboratory instrument. Reason: Potential for sample misidentification. 2014-06-03 Terminated View Details
Z-2066-2014 ACL TOP 300 CTS, automated coagulation laboratory instrument. Reason: Potential for sample misidentification. 2014-06-03 Terminated View Details
Z-2165-2011 Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus Reason: Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results 2011-02-14 Terminated View Details
Z-2244-2013 ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2013-07-19 Terminated View Details
Z-2245-2013 ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2013-07-19 Terminated View Details
Z-2246-2013 ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2013-07-19 Terminated View Details
Z-2247-2013 ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2013-07-19 Terminated View Details
Z-2248-2013 ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2013-07-19 Terminated View Details
Z-2249-2013 ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2013-07-19 Terminated View Details
Z-2250-2013 ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument. 2013-07-19 Terminated View Details
Z-2387-2012 Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 2012-08-03 Terminated View Details
Z-2388-2012 Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 2012-08-03 Terminated View Details
Z-2389-2012 Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 2012-08-03 Terminated View Details
Z-2390-2012 Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 2012-08-03 Terminated View Details
Z-2391-2012 Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 2012-08-03 Terminated View Details
Z-2392-2012 Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low 2012-08-03 Terminated View Details

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