Atlas FDA

ADVIA Centaur CA 125II

FDA 510(k) clearance K200199 · decided 2020-04-06

Clearance details

K-number
K200199
Device name
ADVIA Centaur CA 125II
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2020-01-27
Decision date
2020-04-06
Days to decision
70 days
Clearance type
Traditional
Product code
LTK
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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VIDAS CA 15-3 ASSAY (K080469)bioMerieux, Inc.2009-06-22
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IMMULITE 2500 OM-MA, MODEL L5KOP (K072794)Siemens Medical Solutions Diagnostics2007-11-05
ARCHITECT CA 125 II ASSAY (K042731)Fujirebio Diagnostics,Inc.2004-11-19
ACCESS OV MONITOR ASSAY (K031297)Beckman Coulter, Inc.2003-05-02
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
IMMULITE 2000 PSA (P930027/S037)Siemens Healthcare Diagnostics, Inc.2025-10-30
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