VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS

Myoglobin, Antigen, Antiserum, Control

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 Myoglobin Reagent Pack; Calibrators; Range Verifiers.

Pre-market Notification Details

Device IDK033300
510k NumberK033300
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS
ClassificationMyoglobin, Antigen, Antiserum, Control
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactCharlotte Baker
CorrespondentCharlotte Baker
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeDDR  
Subsequent Product CodeJIS
Subsequent Product CodeJJX
CFR Regulation Number866.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-14
Decision Date2003-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750001033 K033300 000

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