The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Fsh Enzyme Immunassay Test Kit No:kif4057.
| Device ID | K915208 |
| 510k Number | K915208 |
| Device Name: | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | John Chem |
| Correspondent | John Chem MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1991-12-18 |