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FDA 510(k) Application Details - K061065
Device Classification Name
Reagent, Occult Blood
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510(K) Number
K061065
Device Name
Reagent, Occult Blood
Applicant
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM, CA 92807 US
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Contact
JIAN VAECHES
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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
04/17/2006
Decision Date
07/14/2006
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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