ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01

Extractable Antinuclear Antibody, Antigen And Control

PHADIA US INC.

The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01.

Pre-market Notification Details

Device IDK072149
510k NumberK072149
Device Name:ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant PHADIA US INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
ContactMartin Mann
CorrespondentMartin Mann
PHADIA US INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
Product CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-03
Decision Date2008-01-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066010632 K072149 000

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