Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
FDA 510(k) clearance K150168 · decided 2015-11-04
Clearance details
- K-number
- K150168
- Device name
- Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2015-01-26
- Decision date
- 2015-11-04
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- MLM
- Device class
- 2
- Regulation number
- 862.1678
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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| THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (K123343) | Microgenics Corp. | 2013-07-11 |
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| 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 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme recall (Z-2398-2026) | Siemens Healthcare Diagnostics, Inc. | 2026-06-10 |
| Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantit recall (Z-1258-2023) | Siemens Healthcare Diagnostics, Inc. | 2023-03-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024) | Siemens Healthcare Diagnostics | 2025-10-17 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013) | Siemens Healthcare Diagnostics | 2025-10-17 |
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| ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029) | Siemens Healthcare Diagnostics | 2025-07-16 |
| Dimension TPSA Flex reagent cartridge (P000021/S047) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S042) | Siemens Healthcare Diagnostics | 2025-05-22 |
| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |