K974342 is an FDA 510(k) clearance for the ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE. This device is classified as a Dna-reagents, Neisseria (Class II - Special Controls, product code LSL).
Submitted by Roche Molecular Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 28, 1999, 556 days after receiving the submission on November 18, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K974342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1997 |
| Decision Date | May 28, 1999 |
| Days to Decision | 556 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSL — Dna-reagents, Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |