K901086 is an FDA 510(k) clearance for the ENZYMUN TEST(R) T4 (TOTAL THYROXINE). This device is classified as a Enzyme Immunoassay, Carbamazepine (Class II - Special Controls, product code KLT).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 30, 1990, 21 days after receiving the submission on March 9, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3645.
| 510(k) Number | K901086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1990 |
| Decision Date | March 30, 1990 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLT — Enzyme Immunoassay, Carbamazepine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3645 |