VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668

Ferrozine (colorimetric) Iron Binding Capacity

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 Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668.

Pre-market Notification Details

Device IDK061464
510k NumberK061464
Device Name:VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
ClassificationFerrozine (colorimetric) Iron Binding Capacity
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactDarlene J Phillips
CorrespondentDarlene J Phillips
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeJMO  
CFR Regulation Number862.1415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-25
Decision Date2006-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750008537 K061464 000

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