THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
FDA 510(k) clearance K123343 · decided 2013-07-11
Clearance details
- K-number
- K123343
- Device name
- THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
- Applicant
- Microgenics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-31
- Decision date
- 2013-07-11
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- MLM
- Device class
- 2
- Regulation number
- 862.1678
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fremont Blvd., CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| 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 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| QMS Tacrolimus Calibrators, Product code 10015573 recall (Z-0712-2024) | Ortho-Clinical Diagnostics, Inc. | 2024-01-11 |