FDA 510(k) Premarket Notification K103836: ENZYME II CALIBRATOR

Submission Details & Decision

Normalized public record details for 510(k) notification K103836.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K103836

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

ENZYME II CALIBRATOR

Product Code

JIT

Decision Date

2011-02-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2010-12-30

Related Establishments / Registrations

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER Registration: 1000403749 View Registration
SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
HEMAGEN DIAGNOSTICS, INC. Registration: 1181055 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
WATERS CORPORATION Registration: 1218959 View Registration
NOVA BIOMEDICAL CORPORATION Registration: 1219029 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
MEDICA CORP. Registration: 1220972 View Registration
ALDEN MEDICAL LLC Registration: 1221361 View Registration
VERICHEM LABORATORIES, INC. Registration: 1221645 View Registration
CURRIER PLASTICS Registration: 1319436 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319809 View Registration
ABBOTT LABORATORIES Registration: 1415939 View Registration
STANBIO LABORATORY Registration: 1616487 View Registration
Fujirebio Diagnostics, Inc. Registration: 1643621 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
ARKRAY FACTORY USA, INC. Registration: 1832816 View Registration
Biomerica Registration: 2025099 View Registration
INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
Carolina Liquid Chemistries Corp. Registration: 2030861 View Registration
QUALIGEN, INC. Registration: 2032087 View Registration
Diazyme Laboratories, Inc. Registration: 2032900 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
KAMIYA BIOMEDICAL COMPANY LLC Registration: 2084025 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office Registration: 2155 View Registration
DIASORIN INC. Registration: 2182595 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. Registration: 2435505 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Fujirebio Diagnostics, Inc. Registration: 2521625 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
Canon Medical Diagnostics Corporation Fuji Plant. Registration: 3002694097 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
Fujirebio Inc. Registration: 3002895169 View Registration
DIAMOND DIAGNOSTICS Inc Registration: 3003030793 View Registration
FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) Registration: 3003419906 View Registration
ARKRAY Factory, Inc. Registration: 3003422726 View Registration
Agilent Technologies Singapore (International) Pte Ltd. Registration: 3003423869 View Registration
Nagase Diagnostics Co., Ltd. Registration: 3003460426 View Registration
FUJIFILM Healthcare Manufacturing Corporation MIE Office Registration: 3003522182 View Registration
SEKISUI MEDICAL CO., LTD. Tsukuba Plant Registration: 3003539867 View Registration
Tecan Trading AG Registration: 3003559191 View Registration
B.R.A.H.M.S GmbH Registration: 3003561301 View Registration
Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration
DENKA CO., LTD. Registration: 3003871639 View Registration
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH Registration: 3003951180 View Registration
CANTERBURY SCIENTIFIC LTD. Registration: 3003982601 View Registration
SHIMA LABORATORIES CO., LTD. Registration: 3003985394 View Registration
SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration
HYPHEN BIOMED SASU Registration: 3004434070 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
SCITECK Diagnostics Registration: 3004875840 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
OTSUKA ELECTRONICS CO., LTD. Registration: 3005622096 View Registration
FUJIFILM Healthcare Americas Corporation Registration: 3005625991 View Registration
CEZANNE SAS Registration: 3005847079 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
EUROIMMUN US INC. Registration: 3007118747 View Registration
VitalScientific Registration: 3007662974 View Registration
ABBOTT IRELAND Registration: 3008344661 View Registration
Agilent Technologies Inc. Registration: 3009189893 View Registration
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Sysmex America, Inc. Registration: 3009711478 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
Microgenics Corporation Registration: 3010939897 View Registration
EXACT DIAGNOSTICS Registration: 3011926203 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
SHINO-TEST CORPORATION Registration: 3012240236 View Registration
5-DIAGNOSTICS Registration: 3012289015 View Registration
INSTRUMENTATION LABORATORY SPA Registration: 3012348571 View Registration
THE BINDING SITE Registration: 3012471076 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
ATSI Logistics Center ApS Registration: 3013059683 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
PHC Corporation Registration: 3014353045 View Registration
RANDOX LABORATORIES LIMITED Registration: 3014607865 View Registration
Fujirebio Inc. Ube Facility Registration: 3014643041 View Registration
ABBOTT LABORATORIES Registration: 3016438761 View Registration
BIALEX LAB Registration: 3021841051 View Registration
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. Registration: 3027977508 View Registration
PHC Corporation Registration: 3029973107 View Registration
BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Sekisui Diagnostics P.E.I. Inc. Registration: 8020316 View Registration
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IMMUNODIAGNOSTIC SYSTEMS LTD. Registration: 8021924 View Registration
Immunotech SAS, a Beckman Coulter company Registration: 8023018 View Registration
TOSOH CORP. Registration: 8031673 View Registration
AXIS-SHIELD DIAGNOSTICS, LTD. Registration: 8032314 View Registration
Nagase Diagnostics Co., Ltd, Diagnostics Division, Ohito Diagnostics Plant Registration: 8043889 View Registration
WALLAC OY Registration: 8043909 View Registration
Agilent Technologies Denmark ApS Registration: 9610099 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
NIPRO CORPORATION ODATE FACTORY Registration: 9610987 View Registration
ARKRAY, INC. Registration: 9611444 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration
The Binding Site Group Ltd. Registration: 9614373 View Registration
WATERS TECHNOLOGIES IRELAND, LTD. Registration: 9616673 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration
TRINITY BIOTECH, PLC Registration: 9681576 View Registration
SENTINEL CH. SPA Registration: 9681753 View Registration
IBL INTERNATIONAL GMBH Registration: 9710337 View Registration

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