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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 K911047
Device Name OBA(TM) SERUM HCG ASSAY
Applicant
Adeza Biomedical
1240 Elko Dr.
Sunnyvale,  CA  94089
Applicant Contact YUH-GENG TSAY
Correspondent
Adeza Biomedical
1240 Elko Dr.
Sunnyvale,  CA  94089
Correspondent Contact YUH-GENG TSAY
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/08/1991
Decision Date 06/24/1991
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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