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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 K943711
Device Name EZ-SCREEN:PCP
Applicant
Editek, Inc.
1238 Anthony Rd.
Box 908
Burlington,  NC  27215
Applicant Contact CAROLE GOLDEN
Correspondent
Editek, Inc.
1238 Anthony Rd.
Box 908
Burlington,  NC  27215
Correspondent Contact CAROLE GOLDEN
Classification Product Code
LCM  
Date Received08/01/1994
Decision Date 09/09/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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