COAG-A-MATE - RA4
FDA 510(k) clearance K900895 · decided 1990-04-16
Clearance details
- K-number
- K900895
- Device name
- COAG-A-MATE - RA4
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-27
- Decision date
- 1990-04-16
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- KQJ
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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| MULTIFIBREN U (K934326) | Behring Diagnostics, Inc. | 1994-04-19 |
| IL TEST FIBRINOGEN-C (K931721) | Instrumentation Laboratory CO | 1993-08-13 |
| FIBRINOGEN RID TEST KIT (K922416) | The Binding Site, Ltd. | 1993-03-09 |
| MULTIFIBREN (K925988) | Behring Diagnostics, Inc. | 1993-03-01 |
| HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (K923593) | International Technidyne Corp. | 1992-09-22 |
| QBC FIBRINOGEN (K920258) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-06-26 |
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 |