K012966 is an FDA 510(k) clearance for the ROCHE COBAS TAQMAN ANALYZER. This device is classified as a Analyzer, Chemistry, Micro, For Clinical Use (Class I - General Controls, product code JJF).
Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 1, 2002, 150 days after receiving the submission on September 4, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K012966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2001 |
| Decision Date | February 01, 2002 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJF — Analyzer, Chemistry, Micro, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2170 |