The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Human Follicle Stimulating Hormone Assay.
Device ID | K940005 |
510k Number | K940005 |
Device Name: | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Contact | Dennis S Griffin |
Correspondent | Dennis S Griffin BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Product Code | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-03 |
Decision Date | 1994-03-03 |