The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Abbott Tdm Multiconstituent Calibrator, Thermo Scientific Qms Multi-constituent Calibrators.
| Device ID | K120936 |
| 510k Number | K120936 |
| Device Name: | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS |
| Classification | Calibrators, Drug Mixture |
| Applicant | Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Karen Lee |
| Correspondent | Karen Lee Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-28 |
| Decision Date | 2012-12-13 |
| Summary: | summary |