Atlas FDA

ADVIA CHEMISTRY FERRITIN (FRT) METHOD

FDA 510(k) clearance K110736 · decided 2011-08-17

Clearance details

K-number
K110736
Device name
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2011-03-16
Decision date
2011-08-17
Days to decision
154 days
Clearance type
Traditional
Product code
DBF
Device class
2
Regulation number
866.5340
Medical specialty
Immunology
Advisory committee
Immunology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVI recall (Z-0128-2015)Siemens Healthcare Diagnostics, Inc2014-10-24
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ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur recall (Z-0130-2015)Siemens Healthcare Diagnostics, Inc2014-10-24

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Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
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ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16