EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES

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 Eia Kit For The Detction Of Anti-pr3 Antibodies.

Pre-market Notification Details

Device IDK954105
510k NumberK954105
Device Name:EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
ClassificationTest System, Antineutrophil Cytoplasmic Antibodies (anca)
Applicant SCIMEDX CORP. 400 FORD RD. Denville,  NJ  07834
ContactThomas Britten
CorrespondentThomas Britten
SCIMEDX CORP. 400 FORD RD. Denville,  NJ  07834
Product CodeMOB  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-31
Decision Date1996-03-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813545029043 K954105 000

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