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FDA 510(k) Application Details - K003280
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K003280
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES, CA 94547-1803 US
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Contact
JACKIE BUCKLEY
Other 510(k) Applications for this Contact
Regulation Number
864.7470
More FDA Info for this Regulation Number
Classification Product Code
LCP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/19/2000
Decision Date
12/19/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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