K110923 is an FDA 510(k) clearance for the COBAS 4800 CT / NG 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. (Pleasanton, US). The FDA issued a Cleared decision on January 24, 2012, 298 days after receiving the submission on April 1, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K110923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2011 |
| Decision Date | January 24, 2012 |
| Days to Decision | 298 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 |