FDA 510(k) Applications for Medical Device Product Code "MKZ"
(Dna Probe, Nucleic Acid Amplification, Chlamydia)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K080739 | ABBOTT MOLECULAR, INC. | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | 07/10/2008 |
| K091724 | BECTON DICKINSON & CO. | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | 11/13/2009 |
| K081824 | BECTON, DICKINSON & CO. | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | 12/11/2008 |
| K090824 | BECTON, DICKINSON & CO. | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | 06/02/2009 |
| K140446 | BECTON, DICKINSON & CO. | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | 05/20/2014 |
| K061413 | GEN-PROBE, INC. | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | 10/13/2006 |
| K962217 | GEN-PROBE, INC. | GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT | 11/27/1996 |
| K043072 | GEN-PROBE, INC. | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS | 01/27/2005 |
| K053446 | GEN-PROBE, INC. | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | 07/25/2006 |
| K063451 | GEN-PROBE, INC. | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | 01/22/2007 |
| K053287 | ROCHE DIAGNOSTICS CORP. | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | 08/10/2006 |
| K070174 | ROCHE DIAGNOSTICS CORPORATION | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY | 04/16/2007 |
| K110923 | ROCHE MOLECULAR SYSTEMS, INC. | COBAS 4800 CT / NG TEST | 01/24/2012 |
| K973707 | ROCHE MOLECULAR SYSTEMS, INC. | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | 08/04/1999 |
| K964507 | ROCHE MOLECULAR SYSTEMS, INC. | ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST | 06/13/1997 |
| K973718 | ROCHE MOLECULAR SYSTEMS, INC. | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | 12/15/1998 |
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