Atlas FDA

ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR

FDA 510(k) clearance K131307 · decided 2014-01-24

Clearance details

K-number
K131307
Device name
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2013-05-07
Decision date
2014-01-24
Days to decision
262 days
Clearance type
Traditional
Product code
LCP
Device class
2
Regulation number
864.7470
Medical specialty
Hematology
Advisory committee
Hematology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitativ recall (Z-0101-2021)Siemens Healthcare Diagnostics, Inc.2020-10-13
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative me recall (Z-0102-2021)Siemens Healthcare Diagnostics, Inc.2020-10-13
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number recall (Z-2280-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 0063 recall (Z-2281-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05

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