K901135 is an FDA 510(k) clearance for the ENZYMUN TEST(R) INSULIN. This device is classified as a Radioimmunoassay, Immunoreactive Insulin (Class I - General Controls, product code CFP).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 3, 1990, 22 days after receiving the submission on March 12, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1405.
| 510(k) Number | K901135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1990 |
| Decision Date | April 03, 1990 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFP — Radioimmunoassay, Immunoreactive Insulin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1405 |