The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Pantex Irma Lh 1251 Kit.
| Device ID | K910717 |
| 510k Number | K910717 |
| Device Name: | PANTEX IRMA LH 1251 KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
| Contact | Y Chiamori |
| Correspondent | 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 | 1991-02-20 |
| Decision Date | 1991-03-19 |