MLM
9 FDA 510(k) clearances · Product code
147 daysmedian time to decision
758 days90th percentile
9clearances measured
FDA profile
- Official device name
- Enzyme Immunoassay, Tracrolimus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1678
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2012: 31 · 2013: 75 · 2018: 26 · 2022: 23 · 2023: 54 · 2024: 62
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Tacrolimus Assay Kit (K203833) | Shanghai Genext Medical Technology Co., Ltd. | 2023-01-27 |
| Elecsys Tacrolimus (K173857) | Roche Diagnostics | 2018-11-06 |
| Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (K150168) | Siemens Healthcare Diagnostics | 2015-11-04 |
| THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (K123343) | Microgenics Corp. | 2013-07-11 |
| ARCHITECT TACROLIMUS: MODEL 1L77 (K070820) | Fujirebio Diagnostics,Inc. | 2007-08-01 |
| MASSTRAK IMMUNOSUPPRESSANTS KIT (K063868) | Waters Corporation | 2007-05-25 |
| DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 (K060502) | Dade Behring, Inc. | 2006-05-18 |
| EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT (K060385) | Dade Behring, Inc. | 2006-04-06 |
| CEDIA TACROLIMUS ASSAY (K050206) | Microgenics Corp. | 2005-03-15 |
Track MLM automatically
Every clearance here is in the API, with alerts when new ones post.