VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS

Hepatitis A Test (antibody And Igm Antibody)

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Anti-hav Igm-reagent Pack, Calibrator, And Controls.

Pre-market Notification Details

Device IDK060770
510k NumberK060770
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactSarah Parsons
CorrespondentSarah Parsons
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-22
Decision Date2006-09-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750000883 K060770 000

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