K961792 is an FDA 510(k) clearance for the BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA).
Submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on August 21, 1996, 104 days after receiving the submission on May 9, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K961792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1996 |
| Decision Date | August 21, 1996 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1155 |