K860334 is an FDA 510(k) clearance for the VISI-CHECK HLH TEST MONOCLONAL. This device is classified as a Radioimmunoassay, Luteinizing Hormone (Class I - General Controls, product code CEP).
Submitted by Bioclinical Systems, Inc. (St.Louis, US). The FDA issued a Cleared decision on April 21, 1986, 82 days after receiving the submission on January 29, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1485.
| 510(k) Number | K860334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1986 |
| Decision Date | April 21, 1986 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEP — Radioimmunoassay, Luteinizing Hormone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1485 |