K831383 is an FDA 510(k) clearance for the EVENT-TEST SLIDE. This device is classified as a Agglutination Method, Human Chorionic Gonadotropin (Class II - Special Controls, product code JHJ).
Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983, 55 days after receiving the submission on April 28, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K831383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1983 |
| Decision Date | June 22, 1983 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHJ — Agglutination Method, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |