VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III

Alpha-1-antitrypsin, 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 Products Aat Reagent, Calibrator Kit 99 And Aat Performance Verifiers I, Ii And Iii.

Pre-market Notification Details

Device IDK052819
510k NumberK052819
Device Name:VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
ClassificationAlpha-1-antitrypsin, 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 CodeDEM  
Subsequent Product CodeJIX
Subsequent Product CodeJJX
CFR Regulation Number866.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-04
Decision Date2005-12-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750002573 K052819 000
10758750002566 K052819 000
10758750002559 K052819 000

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