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FDA 510(k) Application Details - K073431
Device Classification Name
Reagent, Occult Blood
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510(K) Number
K073431
Device Name
Reagent, Occult Blood
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
3108 AVENIDA OLMEDA
CARLSBAD, CA 92009 US
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Contact
ARMANDO TORRESCANO
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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
12/06/2007
Decision Date
01/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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