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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K911045
Device Name OBA(TM) READER
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 Number862.2300
Classification Product Code
JJQ  
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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