K823313 is an FDA 510(k) clearance for the IN VITRO GAMMACOAT B-HCG RADIO. TEST. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982, 47 days after receiving the submission on November 5, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K823313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1982 |
| Decision Date | December 22, 1982 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |