ELIA SCL-70S IMMUNOASSAY

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

PHADIA GMBH

The following data is part of a premarket notification filed by Phadia Gmbh with the FDA for Elia Scl-70s Immunoassay.

Pre-market Notification Details

Device IDK140493
510k NumberK140493
Device Name:ELIA SCL-70S IMMUNOASSAY
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
Applicant PHADIA GMBH 4169 COMMERCIAL AVE Portage,  MI  49002
ContactMartin R Mann
CorrespondentMartin R Mann
PHADIA GMBH 4169 COMMERCIAL AVE Portage,  MI  49002
Product CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-27
Decision Date2014-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066010892 K140493 000

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