The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Ige Enzyme Immunoassay Test Kit No. Mb-1064.
| Device ID | K874406 |
| 510k Number | K874406 |
| Device Name: | IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 |
| Classification | Ige, Antigen, Antiserum, Control |
| 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 | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1987-11-25 |