The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Immunocoat Progesterone Radioimmunoassay Kit.
| Device ID | K894049 |
| 510k Number | K894049 |
| Device Name: | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Chiamori, Phd |
| Correspondent | Chiamori, Phd PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-09-08 |