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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Enzyme, For Clinical Use
510(k) Number K972024
Device Name CODA AUTOMATED EIA ANALYZER
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact JOHN W NELSON
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact JOHN W NELSON
Regulation Number862.2500
Classification Product Code
JJI  
Date Received06/02/1997
Decision Date 07/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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