ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

Hemoglobin A1c Test System

Siemens Healthcare Diagnostics, Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Enzymatic Hemoglobin Ale (alc_e) Assay.

Pre-market Notification Details

Device IDK200256
510k NumberK200256
Device Name:ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
ClassificationHemoglobin A1c Test System
Applicant Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown,  NY  10591
ContactJulie Warren
CorrespondentJulie Warren
Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown,  NY  10591
Product CodePDJ  
CFR Regulation Number862.1373 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2021-07-02

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