The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Immuchem Lh-mw Elisa.
| Device ID | K922944 |
| 510k Number | K922944 |
| Device Name: | IMMUCHEM LH-MW ELISA |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Contact | Susanne J Graves |
| Correspondent | Susanne J Graves ICN BIOMEDICALS, INC. 3300 HYLAND AVE. Costa Mesa, CA 92626 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1993-02-02 |