THROMBONOSTIKA F1.2
FDA 510(k) clearance K911434 · decided 1991-10-31
Clearance details
- K-number
- K911434
- Device name
- THROMBONOSTIKA F1.2
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-02
- Decision date
- 1991-10-31
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- MIF
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Durham, NC, 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 |
|---|---|---|
| ENZYGNOST F+2 (MONOCLONAL) TEST KIT (K042687) | Dade Behring, Inc. | 2004-12-10 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001) | Organon Teknika Corp. | 1990-03-21 |
| HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001) | Organon Teknika Corp. | 1990-03-21 |
| 9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001) | Organon Teknika Corp. | 1990-03-21 |
| AUTOBAC MIC TEST SYSTEM (N50524/S033) | Organon Teknika Corp. | 1990-01-22 |
| AUTOBAC MIC TEST SYSTEM (N50524/S035) | Organon Teknika Corp. | 1989-12-07 |
| AUTOBAC MIC TEST SYSTEM (N50524/S032) | Organon Teknika Corp. | 1989-06-13 |
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018) | Organon Teknika Corp. | 1989-02-06 |
| AUTOBAC MIC TEST SYSTEM (N50524/S031) | Organon Teknika Corp. | 1988-12-28 |