The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Qms Tacrolimus Assay And Calibrators.
| Device ID | K123343 |
| 510k Number | K123343 |
| Device Name: | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Contact | Karen Lee |
| Correspondent | Karen Lee 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 | 2012-10-31 |
| Decision Date | 2013-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012592 | K123343 | 000 |
| 00884883011830 | K123343 | 000 |