510(k) K173857
- Device
- Elecsys Tacrolimus
- Applicant
- Roche Diagnostics
- 510(k) number
- K173857
- Product code
- MLM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-06
- Date received
- 2017-12-20
- Regulation
- 862.1678
- Classification name
- Enzyme Immunoassay, Tracrolimus
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Khoa Tran
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 1415939
- 1643621
- 1218959
- 3010939897
- 3003951180
- 2517506
- 3008344661
- 9616673
- 9610126
- 3026848661
- 3005333358
- 2521625
- 2432235
Source Documents#
Other 510(k) Records For Product Code MLM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203833 | Tacrolimus Assay Kit | Shanghai Genext Medical Technology Co., Ltd. | 2023-01-27 |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Siemens Healthcare Diagnostics | 2015-11-04 |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Microgenics Corp. | 2013-07-11 |
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | Fujirebio Diagnostics,Inc. | 2007-08-01 |
| K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | Waters Corporation | 2007-05-25 |
| K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 | Dade Behring, Inc. | 2006-05-18 |
| K060385 | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT | Dade Behring, Inc. | 2006-04-06 |
| K050206 | CEDIA TACROLIMUS ASSAY | Microgenics Corp. | 2005-03-15 |
Legacy Summary#
summary
FDA Review#
Decision Summary