The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Ferritin Assay.
| Device ID | K920318 |
| 510k Number | K920318 |
| Device Name: | CEDIA FERRITIN ASSAY |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Patricia M.klimley |
| Correspondent | Patricia M.klimley MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | JMG |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-24 |
| Decision Date | 1992-06-04 |