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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 K082210
Device Name TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
Applicant
Genzyme Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown, Prin Ed Island,  CA C1E 2B9
Applicant Contact PENNY J WHITE
Correspondent
Genzyme Diagnostics P.E.I., Inc.
70 Watts Ave.
Charlottetown, Prin Ed Island,  CA C1E 2B9
Correspondent Contact PENNY J WHITE
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
MQM  
Date Received08/06/2008
Decision Date 12/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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