The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Progesterone Radioimmunoassay Kit.
| Device ID | K931228 |
| 510k Number | K931228 |
| Device Name: | PROGESTERONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | IMMUNOTECH CORP. 130, AVENUE JEAN DE LATTRE DE TASSIGNY-BP 177, 13276 MARSEIL Cedex 9 (france), FR |
| Contact | Prince |
| Correspondent | Prince IMMUNOTECH CORP. 130, AVENUE JEAN DE LATTRE DE TASSIGNY-BP 177, 13276 MARSEIL Cedex 9 (france), FR |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-10 |
| Decision Date | 1993-10-22 |