VITROS XT Chemistry Products ALB-TP Slides

Bromcresol Green Dye-binding, Albumin

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Xt Chemistry Products Alb-tp Slides.

Pre-market Notification Details

Device IDK191316
510k NumberK191316
Device Name:VITROS XT Chemistry Products ALB-TP Slides
ClassificationBromcresol Green Dye-binding, Albumin
Applicant Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester,  NY  14626
ContactDarlene Phillips
CorrespondentDarlene Phillips
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester,  NY  14626
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-15
Decision Date2019-06-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750031771 K191316 000

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