The following data is part of a premarket notification filed by American Dade with the FDA for Stratus(r) Hfsh Fluorometric Enzyme Immunoassay.
Device ID | K873051 |
510k Number | K873051 |
Device Name: | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Contact | Karen H Darcy |
Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Product Code | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1987-10-20 |