Roche Diagnostics Corp. · Class I · Cleared Aug 10, 2006
| K-number | K053287 |
| Device name | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
| Applicant | Roche Diagnostics Corp. |
| Product code | MKZ |
| Device class | Class I |
| Decision date | Aug 10, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 866.3120 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov