The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for Immuchem Prl-mw Elisa.
| Device ID | K922715 |
| 510k Number | K922715 |
| Device Name: | IMMUCHEM PRL-MW ELISA |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| 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 | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-05 |
| Decision Date | 1992-10-05 |