FIBRINOGEN CALIBRATOR KIT
FDA 510(k) clearance K994341 · decided 2000-03-03
Clearance details
- K-number
- K994341
- Device name
- FIBRINOGEN CALIBRATOR KIT
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-23
- Decision date
- 2000-03-03
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- GFX
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Newark, DE, 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 |
|---|---|---|
| FIBRINOGEN CALIBRATOR KIT (K072304) | Dade Behring, Inc. | 2007-09-19 |
| ACA FIBRINOGEN CALIBRATOR (K812628) | E.I. Dupont DE Nemours & Co., Inc. | 1981-11-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |