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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 K893953
Device Name ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
Applicant
Totem Diagnostics, Inc.
520 W. 6th Ave.
4th Floor
Vancouver, B.C. V5z 4h5,  CA
Applicant Contact KING F HUI
Correspondent
Totem Diagnostics, Inc.
520 W. 6th Ave.
4th Floor
Vancouver, B.C. V5z 4h5,  CA
Correspondent Contact KING F HUI
Regulation Number862.1155
Classification Product Code
DHA  
Date Received06/01/1989
Decision Date 08/15/1989
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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