FDA 510(k) Application Details - K790986

Device Classification Name Solution, M-Nitrophenol, Specific Reagent For Cholinesterase

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510(K) Number K790986
Device Name Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
Applicant WAMPOLE LABORATORIES

, US
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Regulation Number 862.3240

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Classification Product Code DMR
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Date Received 05/25/1979
Decision Date 06/28/1979
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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