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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 K961183
Device Name CBI 7520 READER
Applicant
Columbia Bioscience, Inc.
182 Thomas Johson Dr.
Suite 205
Frederick,  MD  21702
Applicant Contact NORMAN JENKINS
Correspondent
Columbia Bioscience, Inc.
182 Thomas Johson Dr.
Suite 205
Frederick,  MD  21702
Correspondent Contact NORMAN JENKINS
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/26/1996
Decision Date 08/02/1996
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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