Atlas FDA

ADVIA CENTAUR VITAMIN D TOTAL ASSAY

FDA 510(k) clearance K110586 · decided 2011-10-14

Clearance details

K-number
K110586
Device name
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2011-03-01
Decision date
2011-10-14
Days to decision
227 days
Clearance type
Traditional
Product code
MRG
Device class
2
Regulation number
862.1825
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Num recall (Z-1655-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for th recall (Z-1656-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for th recall (Z-1657-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for recall (Z-1658-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use recall (Z-1268-2012)Siemens Healthcare Diagnostics, Inc2012-03-21

PMA approvals by this applicant

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Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
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IMMULITE 2000 AFP (P010007/S024)Siemens Healthcare Diagnostics, Inc.2025-10-30
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036)Siemens Healthcare Diagnostics, Inc.2025-08-14
ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16