K-numberK013566
Device nameIMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
ApplicantDiagnostic Products Corp.
Product codeCEW
Device classClass II
Decision dateNov 20, 2001
DecisionSubstantially Equivalent
Regulation862.1545
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