VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE

Enzyme Immunoassay, Gentamicin

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 Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che.

Pre-market Notification Details

Device IDK042479
510k NumberK042479
Device Name:VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE
ClassificationEnzyme Immunoassay, Gentamicin
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactCarey A Mayo
CorrespondentCarey A Mayo
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeLCD  
Subsequent Product CodeDIF
Subsequent Product CodeDLJ
CFR Regulation Number862.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-13
Decision Date2005-01-06
Summary:summary

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