The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Tacrolimus Assay.
| Device ID | K050206 |
| 510k Number | K050206 |
| Device Name: | CEDIA TACROLIMUS ASSAY |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Lisa Charter |
| Correspondent | Lisa Charter MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | MLM |
| CFR Regulation Number | 862.1678 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-28 |
| Decision Date | 2005-03-15 |
| Summary: | summary |