K903628 is an FDA 510(k) clearance for the AIA-PACK IRI. This device is classified as a Radioimmunoassay, Immunoreactive Insulin (Class I - General Controls, product code CFP).
Submitted by Tosoh Corp. (Washington, D.C., US). The FDA issued a Cleared decision on September 7, 1990, 28 days after receiving the submission on August 10, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1405.
| 510(k) Number | K903628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1990 |
| Decision Date | September 07, 1990 |
| Days to Decision | 28 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 |