The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Prolactin Enzyme Immunoassay Test Kit (modified).
| Device ID | K920345 |
| 510k Number | K920345 |
| Device Name: | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | John Chen |
| Correspondent | John Chen 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 | 1992-01-27 |
| Decision Date | 1992-03-18 |