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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
510(k) Number K923337
Device Name ON*SITE ALCOHOL
Applicant
Toxi-Lab, Inc.
2 Goodyear
Irvine,  CA  92718
Applicant Contact STEPHEN K SCHULTHEI
Correspondent
Toxi-Lab, Inc.
2 Goodyear
Irvine,  CA  92718
Correspondent Contact STEPHEN K SCHULTHEI
Regulation Number862.3040
Classification Product Code
DML  
Date Received06/18/1992
Decision Date 01/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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