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FDA 510(k) Application Details - K100817
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K100817
Device Name
Reagent, Occult Blood
Applicant
PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION, NJ 08852-1905 US
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Contact
JEMO KANG, PH.D.
Other 510(k) Applications for this Contact
Regulation Number
864.6550
More FDA Info for this Regulation Number
Classification Product Code
KHE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/19/2010
Decision Date
07/01/2010
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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