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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K902681
Device Name EZ-SCREEN:HCG
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 Number862.1155
Classification Product Code
JHI  
Date Received06/19/1990
Decision Date 08/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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