VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System

Enzymatic Method, Creatinine

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Crbm Slides, Vitros Chemistry Products Crea Slides, Vitros Chemistry Products Tbil Slides, Vitros Xt 7600 Integrated System.

Pre-market Notification Details

Device IDK182063
510k NumberK182063
Device Name:VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
ClassificationEnzymatic Method, Creatinine
Applicant Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester,  NY  14626
ContactMarlene Hanna
CorrespondentMarlene Hanna
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester,  NY  14626
Product CodeJFY  
Subsequent Product CodeCIG
Subsequent Product CodeJJE
Subsequent Product CodeKLT
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-01
Decision Date2018-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750031986 K182063 000
10758750031610 K182063 000

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