K964507 is an FDA 510(k) clearance for the ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST. This device is classified as a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I - General Controls, product code MKZ).
Submitted by Roche Molecular Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 13, 1997, 217 days after receiving the submission on November 8, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K964507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1996 |
| Decision Date | June 13, 1997 |
| Days to Decision | 217 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 |