K972606 is an FDA 510(k) clearance for the PREGNACOL PREGNANCY TEST. This device is classified as a Agglutination Method, Human Chorionic Gonadotropin (Class II - Special Controls, product code JHJ).
Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on August 29, 1997, 49 days after receiving the submission on July 11, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K972606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1997 |
| Decision Date | August 29, 1997 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JHJ - Agglutination Method, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |