The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Roche Cobas Amplicor Ct/ng Test For Chlamydia Trachomatis.
| Device ID | K973718 |
| 510k Number | K973718 |
| Device Name: | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
| Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 |
| Contact | Alex Wesolowski |
| Correspondent | Alex Wesolowski ROCHE MOLECULAR SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 |
| Product Code | MKZ |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-29 |
| Decision Date | 1998-12-15 |
| Summary: | summary |