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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 K032987
Device Name ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
Applicant
Unotech Diagnostics, Inc.
2235 Polvorosa Ave., Suite 220
San Leandro,  CA  94577
Applicant Contact KEN WU
Correspondent
Unotech Diagnostics, Inc.
2235 Polvorosa Ave., Suite 220
San Leandro,  CA  94577
Correspondent Contact KEN WU
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/24/2003
Decision Date 11/17/2003
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
Predetermined Change
Control Plan Authorized		 No
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