The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Ct/ng V2.0 Test.
| Device ID | K132270 |
| 510k Number | K132270 |
| Device Name: | COBAS CT/NG V2.0 TEST |
| Classification | Dna-reagents, Neisseria |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Contact | Wilk Von Gustedt |
| Correspondent | Wilk Von Gustedt ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-22 |
| Decision Date | 2013-12-02 |
| Summary: | summary |