CEDIA TACROLIMUS ASSAY
FDA 510(k) clearance K050206 · decided 2005-03-15
Clearance details
- K-number
- K050206
- Device name
- CEDIA TACROLIMUS ASSAY
- Applicant
- Microgenics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-28
- Decision date
- 2005-03-15
- Days to decision
- 46 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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|---|---|---|
| Tacrolimus Assay Kit (K203833) | Shanghai Genext Medical Technology Co., Ltd. | 2023-01-27 |
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.