510(k) K053287
- Device
- COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K053287
- Product code
- MKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-10
- Date received
- 2005-11-25
- Regulation
- 866.3120
- Classification name
- Dna Probe, Nucleic Acid Amplification, Chlamydia
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THERESA M AMBROSE
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3019837962
- 3012598266
- 3009613136
- 3004141078
- 3006198300
- 2243471
- 2024800
- 2436875
- 3004530258
- 3016838963
- 9610126
- 3005248192
- 3003795116
- 3002444944
- 3025663244
- 3017907743
- 3016608638
- 3026940910
- 3013019728
- 1119779
- 3007420875
- 3038610665
Source Documents#
Other 510(k) Records For Product Code MKZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230451 | Aptima® Chlamydia trachomatis Assay | Hologic, Inc. | 2023-11-16 |
| K140446 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2014-05-20 |
| K110923 | COBAS 4800 CT / NG TEST | Roche Molecular Systems, Inc. | 2012-01-24 |
| K091724 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-11-13 |
| K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2009-06-02 |
| K081824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2008-12-11 |
| K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | Abbott Molecular, Inc. | 2008-07-10 |
| K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY | Roche Diagnostics Corporation | 2007-04-16 |
| K063451 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 | Gen-Probe, Inc. | 2007-01-22 |
| K061413 | APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM | Gen-Probe, Inc. | 2006-10-13 |
| K053446 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 | Gen-Probe, Inc. | 2006-07-25 |
| K043072 | GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS | Gen-Probe, Inc. | 2005-01-27 |
| K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | 1999-08-04 |
| K973718 | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | Roche Molecular Systems, Inc. | 1998-12-15 |
| K964507 | ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST | Roche Molecular Systems, Inc. | 1997-06-13 |
Legacy Summary#
summary
FDA Review#
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