VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS

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 Anti-hcv Controls.

Pre-market Notification Details

Device IDK012561
510k NumberK012561
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactSusan Werner Werner
CorrespondentSusan Werner Werner
ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeJJX  
Subsequent Product CodeMJX
Subsequent Product CodeMJY
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-08
Decision Date2001-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750001156 K012561 000

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