K082210

Substantially Equivalent

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

Applicant: Genzyme Diagnostics P.E.I., Inc.
Product code: CIG
Advisory panel: Clinical Chemistry
Date received: 2008-08-06
Decision date: 2008-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, Prin Ed Island, CA

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