VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK

System, Test, Immunological, Antigen, Tumor

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 Ca 15-3 Calibrators,vitros Immunodiagnostic Products Ca 15-3 Reagent Pack.

Pre-market Notification Details

Device IDK983690
510k NumberK983690
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
ClassificationSystem, Test, Immunological, Antigen, Tumor
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactAnne Zavertnik
CorrespondentAnne Zavertnik
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeMOI  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-21
Decision Date1999-02-02
Summary:summary

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