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FDA 510(k) Application Details - K063693
Device Classification Name
Reagent, Occult Blood
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510(K) Number
K063693
Device Name
Reagent, Occult Blood
Applicant
NEW BAY BIORESEARCH CO. LTD.
3108 AVENIDA OLMEDA
CARLSBAD, CA 92009 US
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Contact
RODRIGO BERLIE
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Regulation Number
864.6550
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Classification Product Code
KHE
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More FDA Info for this Product Code
Date Received
12/13/2006
Decision Date
05/11/2007
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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