SIMPLASTIN EXCEL
FDA 510(k) clearance K864283 · decided 1986-12-04
Clearance details
- K-number
- K864283
- Device name
- SIMPLASTIN EXCEL
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-30
- Decision date
- 1986-12-04
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Kensington, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. recall (Z-0629-03) | Biomerieux, Inc. | 2003-03-06 |
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 |