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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K820392
Device Name ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
Applicant
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Correspondent
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Regulation Number862.3280
Classification Product Code
LAS  
Date Received02/10/1982
Decision Date 03/04/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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