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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Control Materials
510(k) Number K932067
Device Name ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact LEO BRESSLER
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact LEO BRESSLER
Regulation Number862.3280
Classification Product Code
DKC  
Date Received04/29/1993
Decision Date 06/16/1993
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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