VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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 Cocm Reagent, Calibrator Kit 26, Fs Calibrator 1 And Dat Performance Verifiers I, Ii, Iii, Iv.

Pre-market Notification Details

Device IDK062123
510k NumberK062123
Device Name:VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactMichael M Byrne
CorrespondentMichael M Byrne
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeDIO  
Subsequent Product CodeDIF
Subsequent Product CodeDKB
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-25
Decision Date2006-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750002658 K062123 000
10758750002641 K062123 000
10758750002634 K062123 000
10758750002627 K062123 000
10758750002610 K062123 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.