MLM — Enzyme Immunoassay, Tracrolimus Class II
FDA Device Classification
Classification Details
- Product Code
- MLM
- Device Class
- Class II
- Regulation Number
- 862.1678
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K203833 | shanghai genext medical technology co | Tacrolimus Assay Kit | January 27, 2023 |
| K173857 | roche diagnostics | Elecsys Tacrolimus | November 6, 2018 |
| K150168 | siemens healthcare diagnostics | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibra | November 4, 2015 |
| K123343 | microgenics | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | July 11, 2013 |
| K070820 | fujirebio diagnostics | ARCHITECT TACROLIMUS: MODEL 1L77 | August 1, 2007 |
| K063868 | waters corporation | MASSTRAK IMMUNOSUPPRESSANTS KIT | May 25, 2007 |
| K060502 | dade behring | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 | May 18, 2006 |
| K060385 | dade behring | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT | April 6, 2006 |
| K050206 | microgenics | CEDIA TACROLIMUS ASSAY | March 15, 2005 |