The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Hcg Enzyme Immunoassay Test Kit Catalog #mb-1013.
| Device ID | K873872 |
| 510k Number | K873872 |
| Device Name: | HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 |
| Classification | System, Test, Human Chorionic Gonadotropin |
| 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 | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-22 |
| Decision Date | 1987-10-28 |