510(k) K991268
- Device
- GONOSTAT GONOCOCCAL DETECTION KIT
- Applicant
- SIERRA DIAGNOSTICS
- 510(k) number
- K991268
- Product code
- LSL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-11
- Date received
- 1999-04-13
- Regulation
- 866.3390
- Classification name
- Dna-reagents, Neisseria
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD R STONE
- Address
- 1900 K St. NW Washington DC US 20006 20006
FDA Registration Numbers#
- 3019837962
- 3012598266
- 3009613136
- 3004141078
- 3006198300
- 2243471
- 1122376
- 2024800
- 2436875
- 3018348
- 3004530258
- 3016838963
- 9610126
- 3005248192
- 3043226252
- 3003795116
- 2029275
- 3002444944
- 3025663244
- 3017907743
- 1550222
- 3016608638
- 3026940910
- 3012494290
- 3013019728
- 1119779
- 3007420875
- 3038610665
Source Documents#
Other 510(k) Records For Product Code LSL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. | 2024-01-26 |
| K180681 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2018-06-13 |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018-03-21 |
| K173840 | Xpert CT/NG | Cepheid | 2018-03-16 |
| K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017-02-09 |
| K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2014-05-20 |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | Abbott Molecular, Inc. | 2014-05-09 |
| K140887 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2014-05-05 |
| K132270 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2013-12-02 |
| K132251 | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) | Hologic / Gen-Probe Incorporated | 2013-10-17 |
| K121710 | XPERT CT/NG | Cepheid | 2012-12-27 |
| K111409 | APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2012-05-03 |
| K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-11-13 |
| K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-06-05 |
| K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-05-27 |
Legacy Summary#
summary
FDA Review#
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