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ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material

FDA 510(k) clearance K143687 · decided 2015-07-17

Clearance details

K-number
K143687
Device name
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2014-12-24
Decision date
2015-07-17
Days to decision
205 days
Clearance type
Traditional
Product code
JJX
Device class
1
Regulation number
862.1660
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
IMMULITE 2000 PSA (P930027/S039)Siemens Healthcare Diagnostics, Inc.2026-07-27
IMMULITE 2000 AFP (P010007/S026)Siemens Healthcare Diagnostics, Inc.2026-07-27
Atellica IM free PSA II (fPSAII) (P250026)Siemens Healthcare Diagnostics, Inc.2026-05-11
ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026)Siemens Healthcare Diagnostics, Inc.2026-05-11
IMMULITE 2000 AFP (P010007/S025)Siemens Healthcare Diagnostics, Inc.2026-04-21
IMMULITE 2000 PSA (P930027/S038)Siemens Healthcare Diagnostics, Inc.2026-04-21
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