The following data is part of a premarket notification filed by Medix Biotech, Inc. with the FDA for Modified Ferritin Enzyme Imunoassay Test Kit.
Device ID | K920046 |
510k Number | K920046 |
Device Name: | MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
Contact | John Chen |
Correspondent | John Chen MEDIX BIOTECH, INC. 420 LINCOLN CENTRE DR. Foster City, CA 94404 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-06 |
Decision Date | 1992-01-28 |