FDA Product Code
FDA Product Code MLM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1678
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203833 | Tacrolimus Assay Kit | Shanghai Genext Medical Technology Co., Ltd. | 2023-01-27 | Traditional | PDF ↗ |
| K173857 | Elecsys Tacrolimus | Roche Diagnostics | 2018-11-06 | Traditional | PDF ↗ |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Siemens Healthcare Diagnostics | 2015-11-04 | Traditional | PDF ↗ |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Microgenics Corp. | 2013-07-11 | Traditional | PDF ↗ |
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | Fujirebio Diagnostics,Inc. | 2007-08-01 | Traditional | PDF ↗ |
| K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | Waters Corporation | 2007-05-25 | Traditional | PDF ↗ |
| K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 | Dade Behring, Inc. | 2006-05-18 | Traditional | PDF ↗ |
| K060385 | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT | Dade Behring, Inc. | 2006-04-06 | Traditional | PDF ↗ |
| K050206 | CEDIA TACROLIMUS ASSAY | Microgenics Corp. | 2005-03-15 | Traditional | PDF ↗ |
Product code MLM · Class II · Clinical Chemistry. Data: openFDA.