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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
Device Name ALCO-SCREEN
Original Applicant
CHEMATICS, INC.
p.o. box 293
highway 13 south
north webster,  IN  46555
Original Contact carl reynolds
Regulation Number862.3040
Classification Product Code
DIC  
Date Received04/25/2012
Decision Date 03/22/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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