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FDA 510(k) Application Details - K955355
Device Classification Name
Abnormal Hemoglobin Quantitation
More FDA Info for this Device
510(K) Number
K955355
Device Name
Abnormal Hemoglobin Quantitation
Applicant
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES, CA 94547-1803 US
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Contact
KENNETH J KISCO
Other 510(k) Applications for this Contact
Regulation Number
864.7415
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Classification Product Code
GKA
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More FDA Info for this Product Code
Date Received
11/21/1995
Decision Date
04/26/1996
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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