The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Medix Biotech Ige Visual Screening Test Kit.
| Device ID | K874281 |
| 510k Number | K874281 |
| Device Name: | MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| 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 | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1987-12-18 |