K873518 is an FDA 510(k) clearance for the AFFINITY TOTAL THYROXINE IMMUNIT. This device is classified as a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II - Special Controls, product code KLI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 29, 1987, 58 days after receiving the submission on September 1, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1700.
| 510(k) Number | K873518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1987 |
| Decision Date | October 29, 1987 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1700 |