XPERT CT/NG
FDA 510(k) clearance K121710 · decided 2012-12-27
Clearance details
- K-number
- K121710
- Device name
- XPERT CT/NG
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2012-06-11
- Decision date
- 2012-12-27
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- LSL
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cepheid
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Aptima Neisseria gonorrhoeae Assay (K231329) | Hologic, Inc. | 2024-01-26 |
| Aptima Combo 2 Assay (Panther System) (K180681) | Hologic, Inc. | 2018-06-13 |
| cobas CT/NG for use on cobas 6800/8800 systems (K173887) | Roche Molecular Systems, Inc. | 2018-03-21 |
| Xpert CT/NG (K173840) | Cepheid | 2018-03-16 |
| cobas® CT/NG v2.0 Test (K163184) | Roche Molecular Systems, Inc. | 2017-02-09 |
| 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 |
| APTIMA COMBO 2 ASSAY (K111409) | Gen-Probe, Inc. | 2012-05-03 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K091730) | Becton, Dickinson & CO | 2009-11-13 |