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FDA 510(k) Application Details - K031296
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K031296
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BIODIAGNOSTIC INTL
615 NORTH BERRY ST.
# E
BREA, CA 92821 US
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Contact
PAUL ANAND
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Regulation Number
864.7470
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Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
04/23/2003
Decision Date
10/15/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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