K053287 is an FDA 510(k) clearance for the COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS. This device is classified as a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I - General Controls, product code MKZ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 10, 2006, 258 days after receiving the submission on November 25, 2005.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K053287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2005 |
| Decision Date | August 10, 2006 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |