Atlas FDA

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I

FDA 510(k) clearance K102644 · decided 2011-11-23

Clearance details

K-number
K102644
Device name
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2010-09-14
Decision date
2011-11-23
Days to decision
435 days
Clearance type
Traditional
Product code
GKZ
Device class
2
Regulation number
864.5220
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
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PMA approvals by this applicant

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Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
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