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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name alcohol dehydrogenase, specific reagent for ethanol enzyme method
510(k) Number K121256
Model 56001
Device Name ALCO-SCREEN 02
Original Applicant
p.o. box 293
highway 13 south
north webster,  IN  46555
Original Contact carl reynolds
Regulation Number862.3040
Classification Product Code
Date Received04/25/2012
Decision Date 09/12/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No