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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 K121247
Model 55001
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 03/22/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No