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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 K013678
Device Name VICTORCH MEDITEK'S HCG TEST CARD
Applicant
VICTORCH MEDITEK, INC.
7313 CARROLL RD., SUITE A-B
SAN DIEGO,  CA  92121
Applicant Contact PIERCE LIU
Correspondent
CALIFORNIA DEPARTMENT OF HEALTH SERVICES
P.O. BOX 942732 (MS-357)
SACRAMENTO,  CA  94234 -7320
Correspondent Contact RAYMOND WILSON
Regulation Number862.1155
Classification Product Code
DHA  
Date Received11/07/2001
Decision Date 12/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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