Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
FDA 510(k) clearance K143470 · decided 2016-01-31
Clearance details
- K-number
- K143470
- Device name
- Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2014-12-05
- Decision date
- 2016-01-31
- Days to decision
- 422 days
- Clearance type
- Traditional
- Product code
- GIS
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Poway, CA, 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 |
|---|---|---|
| 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 |
| BIOMERIEUX HEMOLAB FIBRINOMAT (K925494) | Biomerieux Vitek, Inc. | 1993-05-18 |
| 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.