The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Modified Fsh Enzyme Immunoassay Test Kit No.mb1050.
| Device ID | K901345 |
| 510k Number | K901345 |
| Device Name: | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | Chen, Ph.d. |
| Correspondent | Chen, Ph.d. 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 | 1990-03-22 |
| Decision Date | 1990-05-10 |