VITROS Immunodiagnostic Products Insulin Calibrators

Calibrator, Secondary

Ortho Clinical Diagnostics

The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Insulin Calibrators.

Pre-market Notification Details

Device IDK171168
510k NumberK171168
Device Name:VITROS Immunodiagnostic Products Insulin Calibrators
ClassificationCalibrator, Secondary
Applicant Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester,  NY  14626
ContactBradley P. Boyer
CorrespondentBradley P. Boyer
Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester,  NY  14626
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-21
Decision Date2017-05-16
Summary:summary

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