GONOSTAT GONOCOCCAL DETECTION KIT
FDA 510(k) clearance K991268 · decided 1999-08-11
Clearance details
- K-number
- K991268
- Device name
- GONOSTAT GONOCOCCAL DETECTION KIT
- Applicant
- Sierra Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1999-04-13
- Decision date
- 1999-08-11
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- LSL
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K140448) | Becton, Dickinson & CO | 2014-05-20 |
| ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (K140354) | Abbott Molecular, Inc. | 2014-05-09 |
| COBAS CT/NG V2.0 TEST (K140887) | Roche Molecular Systems, Inc. | 2014-05-05 |
| COBAS CT/NG V2.0 TEST (K132270) | Roche Molecular Systems, Inc. | 2013-12-02 |
| APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) (K132251) | Hologic / Gen-Probe Incorporated | 2013-10-17 |
| XPERT CT/NG (K121710) | Cepheid | 2012-12-27 |
| APTIMA COMBO 2 ASSAY (K111409) | Gen-Probe, Inc. | 2012-05-03 |
Recalls involving this device
No recalls on record reference this clearance.