K862083 is an FDA 510(k) clearance for the HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY. This device is classified as a Agglutination Method, Human Chorionic Gonadotropin (Class II - Special Controls, product code JHJ).
Submitted by Hygeia Sciences (Newton, US). The FDA issued a Cleared decision on July 2, 1986, 30 days after receiving the submission on June 2, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K862083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1986 |
| Decision Date | July 02, 1986 |
| Days to Decision | 30 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 |