K862109 is an FDA 510(k) clearance for the ENZYMUN TEST TBG. This device is classified as a Radioimmunoassay, Thyroxine-binding Globulin (Class II - Special Controls, product code CEE).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 30, 1986, 27 days after receiving the submission on June 3, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1685.
| 510(k) Number | K862109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1986 |
| Decision Date | June 30, 1986 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEE — Radioimmunoassay, Thyroxine-binding Globulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1685 |