The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Medix Biotech Prolactin Enzyme Immuno. Test Kit.
| Device ID | K873355 |
| 510k Number | K873355 |
| Device Name: | MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | Huang, Phd |
| Correspondent | Huang, Phd MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-20 |
| Decision Date | 1987-10-09 |