The following data is part of a premarket notification filed by Bio-rad with the FDA for Radias Ferritin Enzyme Immunoassay.
| Device ID | K933314 |
| 510k Number | K933314 |
| Device Name: | RADIAS FERRITIN ENZYME IMMUNOASSAY |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Contact | Trevor Wall |
| Correspondent | Trevor Wall BIO-RAD 4000 ALFRED NOBEL DR. Hercules, CA 94547 -1803 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1993-09-08 |