K-numberK083173
Device nameVITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
ApplicantOrtho-Clinical Diagnostics
Product codeJLW
Device classClass II
Decision dateDec 22, 2008
DecisionSubstantially Equivalent
Regulation862.1690
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