The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Radioassay Kit, Im.72 Fsh.
Device ID | K760373 |
510k Number | K760373 |
Device Name: | RADIOASSAY KIT, IM.72 FSH |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-05 |
Decision Date | 1976-11-01 |