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FDA 510(k) Application Details - K060953
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K060953
Device Name
Reagent, Occult Blood
Applicant
YD DIAGNOSTICS CORP.
4304 EVERGREEN LANE
SUITE 101
ANNANDALE, VA 22003 US
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Contact
DUSIC KWAK
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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
04/06/2006
Decision Date
09/18/2006
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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