K903609 is an FDA 510(k) clearance for the SEROTONIN ENZYME IMMUNOASSAY. This device is classified as a Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin (Class I - General Controls, product code CDA).
Submitted by Immunotech Corp. (Cedex 9 (France), FR). The FDA issued a Cleared decision on October 22, 1990, 74 days after receiving the submission on August 9, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1390.
| 510(k) Number | K903609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1990 |
| Decision Date | October 22, 1990 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDA — Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1390 |