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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 K914777
Device Name SIGMA PROCEDURE NO. 333-UV
Applicant
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact LEO BRESSLER
Correspondent
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact LEO BRESSLER
Regulation Number862.3040
Classification Product Code
DML  
Date Received10/23/1991
Decision Date 12/27/1991
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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