VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II

Albumin, Antigen, Antiserum, Control

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 Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I And Ii.

Pre-market Notification Details

Device IDK042643
510k NumberK042643
Device Name:VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
ClassificationAlbumin, Antigen, Antiserum, Control
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 CodeDCF  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-27
Decision Date2004-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750006953 K042643 000
10758750006946 K042643 000

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