K964506 is an FDA 510(k) clearance for the ROCHE COBAS AMPLICOR 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. (Branchburg, US). The FDA issued a Cleared decision on May 21, 1997, 194 days after receiving the submission on November 8, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K964506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1996 |
| Decision Date | May 21, 1997 |
| Days to Decision | 194 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 |