The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Digitoxin Assay.
| Device ID | K896021 |
| 510k Number | K896021 |
| Device Name: | CEDIA DIGITOXIN ASSAY |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Robert K Pigozzi |
| Correspondent | Robert K Pigozzi MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1989-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883005648 | K896021 | 000 |