K896572 is an FDA 510(k) clearance for the REP(TM) SPE PLUS-30 PROCEDURES. This device is classified as a Radioimmunoassay, Immunoreactive Insulin (Class I - General Controls, product code CFP).
Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 11, 1990, 52 days after receiving the submission on November 20, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1405.
| 510(k) Number | K896572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1989 |
| Decision Date | January 11, 1990 |
| Days to Decision | 52 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 |