The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Fsh Irma Immunomag.
| Device ID | K912804 |
| 510k Number | K912804 |
| Device Name: | FSH IRMA IMMUNOMAG |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Neil Y.chiamori,ph.d |
| Correspondent | Neil Y.chiamori,ph.d PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1991-08-12 |