The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Roche Cobas Taqman Analyzer.
| Device ID | K012966 |
| 510k Number | K012966 |
| Device Name: | ROCHE COBAS TAQMAN ANALYZER |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Gary S Riordan |
| Correspondent | Gary S Riordan ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2002-02-01 |
| Summary: | summary |