VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS

Column Chromatography & Color Development, Hydroxyproline

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: Ntx Calibrators, Ntx Reagent Pack, Ntx Controls.

Pre-market Notification Details

Device IDK983674
510k NumberK983674
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
ClassificationColumn Chromatography & Color Development, Hydroxyproline
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 CodeJMM  
CFR Regulation Number862.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-20
Decision Date1999-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750000661 K983674 000
10758750000517 K983674 000

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