K865083 is an FDA 510(k) clearance for the AFFINITY(TM) I UPTAKE IMMUNIT(TM). This device is classified as a Radioassay, Triiodothyronine Uptake (Class II - Special Controls, product code KHQ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 9, 1987, 191 days after receiving the submission on December 30, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1715.
| 510(k) Number | K865083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1986 |
| Decision Date | July 09, 1987 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KHQ — Radioassay, Triiodothyronine Uptake |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1715 |