VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS

Single (specified) Analyte Controls (assayed And Unassayed)

ORTHO-CLINICAL DIAGNOSTICS

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Vitamin B12 Range Verifiers.

Pre-market Notification Details

Device IDK013900
510k NumberK013900
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactMarlene A Shulman
CorrespondentMarlene A Shulman
ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-23
Decision Date2001-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750000937 K013900 000

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