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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K955707
Device Name ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
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
DHA  
Date Received12/15/1995
Decision Date 05/02/1996
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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