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FDA 510(k) Application Details - K200256
Device Classification Name
More FDA Info for this Device
510(K) Number
K200256
Device Name
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
511 Benedict Avenue
Tarrytown, NY 10591 US
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Contact
Julie Warren
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Regulation Number
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Classification Product Code
PDJ
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Date Received
02/03/2020
Decision Date
07/02/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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