K200256

Substantially Equivalent

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: PDJ
Advisory panel: Clinical Chemistry
Date received: 2020-02-03
Decision date: 2021-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, US

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