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FDA 510(k) Application Details - K122472
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K122472
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
4000 ALFRED NOBEL DRIVE
HERCULES, CA 94547 US
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Contact
JACKIE BUCKLEY
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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
08/14/2012
Decision Date
10/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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