K831125 is an FDA 510(k) clearance for the BTC URINE LCG ASSAY. This device is classified as a Agglutination Method, Human Chorionic Gonadotropin (Class II - Special Controls, product code JHJ).
Submitted by Btc Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1983, 30 days after receiving the submission on April 5, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K831125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1983 |
| Decision Date | May 05, 1983 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JHJ — Agglutination Method, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |