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FDA 510(k) Application Details - K131488
Device Classification Name
Bromcresol Green Dye-Binding, Albumin
More FDA Info for this Device
510(K) Number
K131488
Device Name
Bromcresol Green Dye-Binding, Albumin
Applicant
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 HENDERSON DRIVE
WEST CALDWELL, NJ 07006 US
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Contact
HYMAN KATZ
Other 510(k) Applications for this Contact
Regulation Number
862.1035
More FDA Info for this Regulation Number
Classification Product Code
CIX
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More FDA Info for this Product Code
Date Received
05/23/2013
Decision Date
08/19/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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