K920109 is an FDA 510(k) clearance for the IMX INSULIN. This device is classified as a Radioimmunoassay, Immunoreactive Insulin (Class I - General Controls, product code CFP).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 7, 1992, 118 days after receiving the submission on January 10, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1405.
| 510(k) Number | K920109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1992 |
| Decision Date | May 07, 1992 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CFP — Radioimmunoassay, Immunoreactive Insulin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1405 |