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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name visual, pregnancy hcg, prescription use
510(k) Number K033297
Device Name ZAP HCG TEST, MODEL 8001
Applicant
ZBX CORPORATION
42 LAIRD DRIVE
TORONTO,  CA M4G 3T2
Applicant Contact TRACY YANG
Correspondent
ZBX CORPORATION
42 LAIRD DRIVE
TORONTO,  CA M4G 3T2
Correspondent Contact TRACY YANG
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/14/2003
Decision Date 03/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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