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FDA 510(k) Application Details - K173212
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K173212
Device Name
Reagent, Occult Blood
Applicant
Alfa Scientific Designs, Inc.
13200 Gregg St
Poway, CA 92064 US
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Contact
Wen Hua Fan
Other 510(k) Applications for this Contact
Regulation Number
864.6550
More FDA Info for this Regulation Number
Classification Product Code
KHE
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More FDA Info for this Product Code
Date Received
10/02/2017
Decision Date
02/15/2018
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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