ENZYGNOST F+2 (MONOCLONAL) TEST KIT
FDA 510(k) clearance K042687 · decided 2004-12-10
Clearance details
- K-number
- K042687
- Device name
- ENZYGNOST F+2 (MONOCLONAL) TEST KIT
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-29
- Decision date
- 2004-12-10
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- MIF
- Device class
- 2
- Regulation number
- 864.7320
- 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 |
|---|---|---|
| THROMBONOSTIKA F1.2 (K964934) | Organon Teknika Corp. | 1997-03-18 |
| TPP (K962176) | Panbio, Inc. | 1996-10-18 |
| ENZYGNOST F 1+2 (K922934) | Behring Diagnostics, Inc. | 1992-11-16 |
| DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA (K920895) | Baxter Diagnostics, Inc. | 1992-06-04 |
| THROMBONOSTIKA F1.2 (K911434) | Organon Teknika Corp. | 1991-10-31 |
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 |