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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K970425
Device Name EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
Applicant
Excel Scientific, Inc.
23071 La Palma Ave.
Yorba Linda,  CA  92887
Applicant Contact MIN-LEE CHENG
Correspondent
Excel Scientific, Inc.
23071 La Palma Ave.
Yorba Linda,  CA  92887
Correspondent Contact MIN-LEE CHENG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received02/04/1997
Decision Date 03/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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