The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Amplicor Ct/ng Test For Chlamydia Trachomatis.
| Device ID | K053287 |
| 510k Number | K053287 |
| Device Name: | COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
| Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | MKZ |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2006-08-10 |
| Summary: | summary |