The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Lh Irma Immunomag.
| Device ID | K911050 |
| 510k Number | K911050 |
| Device Name: | LH IRMA IMMUNOMAG |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Neil Y Chiamori |
| Correspondent | Neil Y Chiamori PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1991-04-12 |