VITROS CHEMISTRY PRODUCTS TRIG SLIDES

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

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 Trig Slides.

Pre-market Notification Details

Device IDK130332
510k NumberK130332
Device Name:VITROS CHEMISTRY PRODUCTS TRIG SLIDES
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactGaozhen Hang
CorrespondentGaozhen Hang
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-11
Decision Date2013-05-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750008889 K130332 000
10758750004768 K130332 000

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