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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 K933794
Device Name ANI BIOCARD(TM) HCG TEST
Applicant
Canadian Bioclinical, Ltd.
120 W. Beaver Creek
Richmond Hill
Ontario, Canada,  CA L4B 1L2
Applicant Contact JEREMY CLAPP
Correspondent
Canadian Bioclinical, Ltd.
120 W. Beaver Creek
Richmond Hill
Ontario, Canada,  CA L4B 1L2
Correspondent Contact JEREMY CLAPP
Regulation Number862.1155
Classification Product Code
LCX  
Date Received08/04/1993
Decision Date 05/19/1994
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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