FDA 510(k) Application Details - K961656

Device Classification Name Colorimetry, Cholinesterase

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510(K) Number K961656
Device Name Colorimetry, Cholinesterase
Applicant EQM RESEARCH, INC.
2585 MONTANA AVE.
CINCINNATI, OH 45211 US
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Contact J. PATRICK EBERLY
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Regulation Number 862.3240

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Classification Product Code DIH
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Date Received 04/30/1996
Decision Date 11/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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