VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS

Single (specified) Analyte Controls (assayed And Unassayed)

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 Cortisol Range Verifiers.

Pre-market Notification Details

Device IDK984011
510k NumberK984011
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
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 CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-10
Decision Date1998-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750000951 K984011 000

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