Atlas FDA

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

FDA 510(k) clearance K161954 · decided 2017-03-09

Clearance details

K-number
K161954
Device name
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2016-07-18
Decision date
2017-03-09
Days to decision
234 days
Clearance type
Traditional
Product code
JGS
Device class
2
Regulation number
862.1665
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

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Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate t recall (Z-0496-2025)Siemens Healthcare Diagnostics, Inc.2024-11-20
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 recall (Z-1421-2020)Siemens Healthcare Diagnostics, Inc.2020-03-02

PMA approvals by this applicant

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Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
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