VITROS AFP

Kit, Test,alpha-fetoprotein For Testicular Cancer

Ortho Clinical Diagnostics

The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Afp.

Pre-market Notification Details

Device IDK213626
510k NumberK213626
Device Name:VITROS AFP
ClassificationKit, Test,alpha-fetoprotein For Testicular Cancer
Applicant Ortho Clinical Diagnostics Felindre Meadows Pencoed,  GB CF35 5PZ
ContactDeclan Hynes
CorrespondentDeclan Hynes
Ortho Clinical Diagnostics Felindre Meadows Pencoed,  GB CF35 5PZ
Product CodeLOJ  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-17
Decision Date2022-06-15

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