VITROS Chemistry Products HsCRP Reagent

C-reactive Protein, Antigen, Antiserum, And Control

Ortho Clinical Diagnostics

The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Chemistry Products Hscrp Reagent.

Pre-market Notification Details

Device IDK160712
510k NumberK160712
Device Name:VITROS Chemistry Products HsCRP Reagent
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester,  NY  14626
ContactMarlene Hanna
CorrespondentMarlene Hanna
Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester,  NY  14626
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-15
Decision Date2017-07-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750006915 K160712 000
10758750001965 K160712 000
10758750001637 K160712 000

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