K790002 is an FDA 510(k) clearance for the PREGNANCY TEST KIT, DAISY 2 IN HOME. This device is classified as a Agglutination Method, Human Chorionic Gonadotropin (Class II - Special Controls, product code JHJ).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1979, 30 days after receiving the submission on January 2, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K790002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1979 |
| Decision Date | February 01, 1979 |
| 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 |