Atlas FDA

ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR

FDA 510(k) clearance K110874 · decided 2012-01-20

Clearance details

K-number
K110874
Device name
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2011-03-29
Decision date
2012-01-20
Days to decision
297 days
Clearance type
Traditional
Product code
JZG
Device class
2
Regulation number
866.5630
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

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