K865105 is an FDA 510(k) clearance for the AFFINITY(TM) SYSTEM. This device is classified as a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I - General Controls, product code JJE).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 12, 1987, 72 days after receiving the submission on December 30, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2160.
| 510(k) Number | K865105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1986 |
| Decision Date | March 12, 1987 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2160 |