Panels › Clinical Chemistry › Product code MLM · Class 2
Enzyme Immunoassay, Tracrolimus
Regulation 862.1678
0510(k)s in 12 months (9 all time)
1recalls in 12 months (13 all time)
8recalls that name a 510(k)
Top companies in MLM
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 1 | 7 |
| Microgenics Corp. | 2 | 1 |
| Abbott Laboratories HPD/ADD/GPRD | 0 | 2 |
| Dade Behring, Inc. | 2 | 0 |
| Diasorin Inc. | 0 | 2 |
| Abbott Laboratories | 0 | 1 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Roche Diagnostics | 1 | 0 |
| Shanghai Genext Medical Technology Co., Ltd. | 1 | 0 |
| Waters Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 2023 | K203833 | Tacrolimus Assay Kit Shanghai Genext Medical Technology Co., Ltd., CN | MLM |
| Nov 6, 2018 | K173857 | Elecsys Tacrolimus Roche Diagnostics | MLM |
| Nov 4, 2015 | K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) Siemens Healthcare Diagnostics | MLM |
| Jul 11, 2013 | K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS Microgenics Corp. | MLM |
| Aug 1, 2007 | K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 Fujirebio Diagnostics,Inc. | MLM |
| May 25, 2007 | K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT Waters Corporation | MLM |
| May 18, 2006 | K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 Dade Behring, Inc. | MLM |
| Apr 6, 2006 | K060385 | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT Dade Behring, Inc. | MLM |
| Mar 15, 2005 | K050206 | CEDIA TACROLIMUS ASSAY Microgenics Corp. | MLM |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.