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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diazo colorimetry, bilirubin
510(k) Number K093623
Device Name GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL AVE.
BEDFORD,  MA  01730
Applicant Contact CAROL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
180 HARTWELL AVE.
BEDFORD,  MA  01730
Correspondent Contact CAROL MARBLE
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Codes
GLK   JJY   MQM  
Date Received11/23/2009
Decision Date 06/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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