The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Follicle Stimulating Hormone (hfsh).
| Device ID | K871317 |
| 510k Number | K871317 |
| Device Name: | FOLLICLE STIMULATING HORMONE (HFSH) |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Contact | Burns, Phd |
| Correspondent | Burns, Phd IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-02 |
| Decision Date | 1987-05-20 |