The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Medix Visual Serumo Hcg L10/10 Test Hcg Enzyme Imm.
| Device ID | K850987 |
| 510k Number | K850987 |
| Device Name: | MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | MEDIX BIOTECH, INC. 1420 STAFFORD ST. Redwood City, CA 94063 |
| Contact | Shaw J Bian |
| Correspondent | Shaw J Bian MEDIX BIOTECH, INC. 1420 STAFFORD ST. Redwood City, CA 94063 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-11 |
| Decision Date | 1985-04-08 |