The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Digoxin Plus Assay.
| Device ID | K941255 |
| 510k Number | K941255 |
| Device Name: | CEDIA DIGOXIN PLUS ASSAY |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Patricia M Klimey |
| Correspondent | Patricia M Klimey MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1994-06-13 |