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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 K853453
Device Name BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER
Applicant
Bio Automed Systems, Inc.
485 Macara Ave. #903
Sunnyvale,  CA  94086
Applicant Contact ERNEST TROD
Correspondent
Bio Automed Systems, Inc.
485 Macara Ave. #903
Sunnyvale,  CA  94086
Correspondent Contact ERNEST TROD
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/16/1985
Decision Date 09/30/1985
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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