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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, Phencyclidine
510(k) Number K981292
Device Name QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) 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
Classification Product Code
LCM  
Date Received04/09/1998
Decision Date 05/26/1998
Decision Substantially Equivalent (SESE)
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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