The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Micro-plate Reader, Mdx-1.
| Device ID | K894400 |
| 510k Number | K894400 |
| Device Name: | MICRO-PLATE READER, MDX-1 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Contact | Madeleine Justice |
| Correspondent | Madeleine Justice MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1989-10-23 |