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 |