K894416 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) IGG REAGENTS. This device is classified as a Reagent, Immunoassay, Igg (Class I - General Controls, product code KTO).
Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on August 1, 1989, 15 days after receiving the submission on July 17, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5530.
| 510(k) Number | K894416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1989 |
| Decision Date | August 01, 1989 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KTO — Reagent, Immunoassay, Igg |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5530 |