VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

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 Hbsag Controls.

Pre-market Notification Details

Device IDK011250
510k NumberK011250
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactAnn Quinn
CorrespondentAnn Quinn
Ortho-Clinical Diagnostics, Inc. 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 Received2001-04-24
Decision Date2001-06-13

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