The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas 4800 Ct / Ng Test.
| Device ID | K110923 |
| 510k Number | K110923 |
| Device Name: | COBAS 4800 CT / NG TEST |
| Classification | Dna Probe, Nucleic Acid Amplification, Chlamydia |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Contact | James Bonds |
| Correspondent | James Bonds ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Product Code | MKZ |
| Subsequent Product Code | LSL |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-01 |
| Decision Date | 2012-01-24 |
| Summary: | summary |