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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, Opiates
510(k) Number K900203
Device Name EZ-SCREEN:OPIATES
Applicant
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact GOLDEN, PHD
Correspondent
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact GOLDEN, PHD
Regulation Number862.3650
Classification Product Code
DJG  
Date Received01/16/1990
Decision Date 03/09/1990
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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