Test, Fibrinogen
Hematology · 21 CFR 864.7340
Recent MDR events
68 adverse event reports on file
- INRATIOJan 19, 2007InjuryHemosense, Inc.2954730-2007-00032
- INRATIOJan 9, 2007MalfunctionHemosense, Inc.2954730-2007-00016
- INRATIOJan 9, 2007MalfunctionHemosense, Inc.2954730-2007-00008
- INRATIOJan 9, 2007MalfunctionHemosense, Inc.2954730-2007-00005
- INRATIOJan 9, 2007MalfunctionHemosense, Inc.2954730-2007-00015
- INRATIOJan 9, 2007MalfunctionHemosense, Inc.2954730-2007-00010
- INRATIOJan 9, 2007MalfunctionHemosense, Inc.2954730-2007-00017
- INRATIOJan 9, 2007MalfunctionHemosense, Inc.2954730-2007-00014
- INRATIOSep 8, 2006InjuryHemosense, Inc.2954730-2006-00491
- INRATIOSep 8, 2006MalfunctionHemosense, Inc.2954730-2006-00488
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
17 firms currently registered for this product code
Kamiya Biomedical Company Llc
Tukwila, WA, US
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Diazyme Laboratories, Inc.
POWAY, CA, US
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Fisher Diagnostics
MIDDLETOWN, VA, US
R2 Diagnostics, Inc.
SOUTH BEND, IN, US
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
510(k) clearances
13 clearances for this product code
- Diazyme LaboratoriesJan 31, 2016
K143470 · Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
- R2 Diagnostics, Inc.Nov 29, 2004
K042919 · FIBROTEK FIB
- Kamiya Biomedical Co.Dec 6, 1999
K993482 · K-ASSAY FIBRINOGEN
- Ortho Diagnostic Systems, Inc.Nov 29, 1996
K963902 · QUANTITATIVE FIBRINOGEN ASSAY
- Diagnostic SpecialtiesAug 30, 1994
K941001 · ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
- Biomerieux Vitek, Inc.May 18, 1993
K925494 · BIOMERIEUX HEMOLAB FIBRINOMAT
- Instrumentation Laboratory COOct 26, 1992
K923921 · IL TEST PT FIBRINOGEN HS
- Sigma Diagnostics, Inc.Oct 9, 1991
K913061 · FIBRINOGEN DETERMINATION KIT