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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 K963233
Device Name EZ-SCREEN PROFILE
Applicant
Editek, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact CAROLE GOLDEN
Correspondent
Editek, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact CAROLE GOLDEN
Classification Product Code
LCM  
Subsequent Product Codes
DIG   DIO   DKZ   JXO   LDJ  
Date Received08/19/1996
Decision Date 10/31/1996
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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