BIOMERIEUX HEMOLAB FIBRINOMAT
FDA 510(k) clearance K925494 · decided 1993-05-18
Clearance details
- K-number
- K925494
- Device name
- BIOMERIEUX HEMOLAB FIBRINOMAT
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-02
- Decision date
- 1993-05-18
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- GIS
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hazelwood, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set (K143470) | Diazyme Laboratories | 2016-01-31 |
| FIBROTEK FIB (K042919) | R2 Diagnostics, Inc. | 2004-11-29 |
| K-ASSAY FIBRINOGEN (K993482) | Kamiya Biomedical Co. | 1999-12-06 |
| QUANTITATIVE FIBRINOGEN ASSAY (K963902) | Ortho Diagnostic Systems, Inc. | 1996-11-29 |
| ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (K941001) | Diagnostic Specialties | 1994-08-30 |
| IL TEST PT FIBRINOGEN HS (K923921) | Instrumentation Laboratory CO | 1992-10-26 |
| FIBRINOGEN DETERMINATION KIT (K913061) | Sigma Diagnostics, Inc. | 1991-10-09 |
| ABS CADKIT (K910636) | Panbio, Inc. | 1991-04-29 |
| FIBRINOTEST(TM) - FIBRINOGEN ASSAY (K903874) | Haemachem, Inc. | 1991-02-14 |
| FIBRINOGENTEST-O (K881685) | Diatech, Inc. | 1988-08-09 |
| KINETIC FIBRINOGEN ASSAY (K881150) | Bio/Data Corp. | 1988-03-28 |
| ASSAY KIT, THROMBO-SCREEN (K781880) | Pacific Hemostasis | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146) | Biomerieux Vitek, Inc. | 2001-10-17 |
| VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145) | Biomerieux Vitek, Inc. | 2001-06-25 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142) | Biomerieux Vitek, Inc. | 2001-05-30 |
| VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141) | Biomerieux Vitek, Inc. | 2001-05-14 |
| VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140) | Biomerieux Vitek, Inc. | 2001-03-09 |
| VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138) | Biomerieux Vitek, Inc. | 2000-08-11 |