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FDA 510(k) Application Details - K061093
Device Classification Name
Colorimetry, Cholinesterase
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510(K) Number
K061093
Device Name
Colorimetry, Cholinesterase
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
THERESA M AMBROSE
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Regulation Number
862.3240
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Classification Product Code
DIH
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More FDA Info for this Product Code
Date Received
04/19/2006
Decision Date
07/03/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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