BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
FDA 510(k) clearance K140446 · decided 2014-05-20
Clearance details
- K-number
- K140446
- Device name
- BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2014-02-21
- Decision date
- 2014-05-20
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MKZ
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Aptima® Chlamydia trachomatis Assay (K230451) | Hologic, Inc. | 2023-11-16 |
| COBAS 4800 CT / NG TEST (K110923) | Roche Molecular Systems, Inc. | 2012-01-24 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K091724) | Becton, Dickinson & CO | 2009-11-13 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K090824) | Becton, Dickinson & CO | 2009-06-02 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K081824) | Becton, Dickinson & CO | 2008-12-11 |
| ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739) | Abbott Molecular, Inc. | 2008-07-10 |
| AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY (K070174) | Roche Diagnostics Corporation | 2007-04-16 |
| GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451) | Gen-Probe, Inc. | 2007-01-22 |
| APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413) | Gen-Probe, Inc. | 2006-10-13 |
| COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K053287) | Roche Diagnostics Corp. | 2006-08-10 |
| GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (K053446) | Gen-Probe, Inc. | 2006-07-25 |
| GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS (K043072) | Gen-Probe, Inc. | 2005-01-27 |
Recalls involving this device
No recalls on record reference this clearance.