Accriva Diagnostics, Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3002721930

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002721930
FEI Number
2250033
Entity Name
Accriva Diagnostics, Inc.
City/State/Country
San Diego, CA, US
Establishment Address
6260 Sequence Drive, San Diego, CA 92121, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Accriva Diagnostics, Inc. (Owner Number: 10048042)
Owner / Operator Contact Address
6260 Sequence Drive, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K050016
PMA Number
N/A

All Registered Proprietary Names

86000 - VerifyNow Instrument 85063 - Validation Kit 86000D - VerifyNow Instrument 85047 - WQC 86000L - VerifyNow Instrument 86003D - VerifyNow Instrument 86000RF - VerifyNow Instrument 86003L - VerifyNow Instrument 70068 - EQC 86003 - VerifyNow Instrument 85062 - Preventative Maintenance Kit 85053 - Aspirin Test 85053-10 - Aspirin Test 85047 - WQC 85225 - PRUTest 85065 - VerifyNow System, International 85066 - VerifyNow System, International RQCHRT - RxDx Whole Blood Quality Control Heparin R-HRT480P - Heparin Response Test J201 - PT Cuvettes HRS.110 - Hemochron Response Instrument HRS.RF - Hemochron Response Instrument HRS.110L - Hemochron Response Instrument HRS.110D - Hemochron Response Instrument AVOX1000E - Whole Blood Oximeter Instrument C100B - Avoximeter 1000E Cuvettes AVOX1000EL - Whole Blood Oximeter Instrument AVOX1000ERF - Whole Blood Oximeter Instrument AVOX1000ED - Whole Blood Oximeter Instrument E-QCYO - Whole Blood Oximeter Optical QC Filters PDAO - Celite Protamine Dose Assay HRDM3CD - Hemochron Data Manager V3 JEN-QC - Hemochron Electronic System Verification, Normal HE-J04 - Hemochron Electronic System Verification Kit J-1001 - Hemochron Temperature Verification Cartrdige JEA-QC - Hemochron Electronic System Verification, Abnormal GH100 - GEM Hemochron 100 System GH100L - GEM Hemochron 100 System JACT-LR - ACT-LR Cuvettes J201C - Citrate PT Cuvettes SU50I - Surgicutt Bleeding Time Device RQCPRT - RxDx Whole Blood Quality Control Protamine R-PRT400 - Celite Protamine Response Test R-PRT200 - Celite Protamine Response Test 85425 - P2Y12 Test, International 85064 - P2Y12 Test, International 85064-PRO - P2Y12 Test, International JACT+ - ACT+ Cuvettes TF50I - Tenderfoot Newborn Heel Incision Device TFM50I - Tenderfoot Micro-Preemie Heel Incision Device TFP1000I - Tenderfoot Preemie Heel Incision Device TF1000I - Tenderfoot Newborn Heel Incision Device TF200I - Tenderfoot Newborn Heel Incision Device TFT50I - Tenderfoot Toddler Heel Incision Device TFP200I - Tenderfoot Preemie Heel Incision Device TFP50I - Tenderfoot Preemie Heel Incision Device 85310 - IIb/IIIa Test J103 - APTT Cuvettes HRFTK-ACT - Kaolin ACT Tubes HE-ESV - Electronic System Verification Tube HR1003 - Temperature Verification Tube ROTEM Sigma ELITE - Hemochron ELITE Instrument ELITEDEMO - Hemochron ELITE Instrument ELITERF - Hemochron ELITE Instrument RPM-CD - Report Maker V61 ELITEL - Hemochron ELITE Instrument

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2014-12-09
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2014-12-09
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2014-12-09
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2015-11-20
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2015-02-27
KFF Assay, Heparin Hematology Class 2 864.7525 2014-12-01
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2014-12-01
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2014-12-01
KQG Instrument, Coagulation Hematology Class 2 864.5400 2014-12-01
DQA Oximeter Cardiovascular Class 2 870.2700 2014-12-01
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2014-12-01
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2014-12-01
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2022-01-03
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2022-01-03
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2022-01-03
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2014-12-01
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2014-12-01
JCA Device, Bleeding Time Hematology Class 2 864.6100 2014-12-01
GFT Protamine Sulphate Hematology Class 2 864.7525 2014-12-01
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2014-12-09
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2014-12-01
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-03-30
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2014-12-09
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2014-12-01
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2014-12-01
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2014-12-01
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2023-12-28
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2014-12-01

Official Correspondent

Paula Morgan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Accriva Diagnostics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K980242 Instrumentation Laboratory CO IL TEST HEPARIN 1998-03-19
K020679 Hemosense, Inc. INRATIO 2002-05-06
K070005 Instrumentation Laboratory CO HEMOSIL RECOMBIPLASTIN 2G 2007-08-15
K931117 Instrumentation Laboratory CO ASSESS(TM) LOW ABNORMAL CONTROL 1994-03-30
K933252 Instrumentation Laboratory CO IL TEST (TM) PT-FIBRINOGEN HS PLUS 1993-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0077-2019 Instrumentation Laboratory Co. 2
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.
Z-0832-2015 Instrumentation Laboratory Co. 2
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).
Z-0895-2018 Instrumentation Laboratory Co. 2
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Z-1246-06 Instrumentation Laboratory Co. 2
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.
Z-1247-06 Instrumentation Laboratory Co. 2
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002721930. Last updated year: 2026. Please use registration number 3002721930 when referencing this establishment in official correspondence.
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