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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, Amphetamine
510(k) Number K905700
Device Name EZ-SCREEN: AMPHETAMINES
Applicant
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact CAROLE GOLDEN
Correspondent
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact CAROLE GOLDEN
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received12/20/1990
Decision Date 01/15/1991
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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