Elecsys Tacrolimus
FDA 510(k) clearance K173857 · decided 2018-11-06
Clearance details
- K-number
- K173857
- Device name
- Elecsys Tacrolimus
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2017-12-20
- Decision date
- 2018-11-06
- Days to decision
- 321 days
- Clearance type
- Traditional
- Product code
- MLM
- Device class
- 2
- Regulation number
- 862.1678
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, 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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| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |