SCIMEDX PHASE II PR3 IGG ANTIBODY EIA

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

SCIMEDX CORP.

The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Scimedx Phase Ii Pr3 Igg Antibody Eia.

Pre-market Notification Details

Device IDK010287
510k NumberK010287
Device Name:SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
ClassificationTest System, Antineutrophil Cytoplasmic Antibodies (anca)
Applicant SCIMEDX CORP. 400 FORD RD. Denville,  NJ  07834
ContactGary Lehnus
CorrespondentGary Lehnus
SCIMEDX CORP. 400 FORD RD. Denville,  NJ  07834
Product CodeMOB  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-31
Decision Date2001-03-16

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