The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Human Growth Hormone Enzyme Immunoassay Mb-1015.
| Device ID | K896643 |
| 510k Number | K896643 |
| Device Name: | HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 |
| Classification | Radioimmunoassay, Human Growth 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 | CFL |
| CFR Regulation Number | 862.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-24 |
| Decision Date | 1989-12-29 |