The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Visi-check Hlh Test Monoclonal.
| Device ID | K860334 |
| 510k Number | K860334 |
| Device Name: | VISI-CHECK HLH TEST MONOCLONAL |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Contact | Watkins, Ph.d. |
| Correspondent | Watkins, Ph.d. BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis, MO 63139 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-29 |
| Decision Date | 1986-04-21 |