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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Barbiturate
510(k) Number K974712
Device Name QUIKSTRIP ONE STEP BARBITURATE TEST
Applicant
Syntron Bioresearch, Inc.
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Applicant Contact CLEVE W LAIRD
Correspondent
Syntron Bioresearch, Inc.
1420 Los Angeles Ave. Suite 201
Simi Valley,  CA  93065
Correspondent Contact CLEVE W LAIRD
Regulation Number862.3150
Classification Product Code
DIS  
Date Received12/17/1997
Decision Date 02/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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