ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01

Anti-dna 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 Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01.

Pre-market Notification Details

Device IDK072393
510k NumberK072393
Device Name:ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
ClassificationAnti-dna Antibody, Antigen And Control
Applicant PHADIA US INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
ContactMartin R Mann
CorrespondentMartin R Mann
PHADIA US INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
Product CodeLSW  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-27
Decision Date2007-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066010557 K072393 000
07333066013879 K072393 000
07333066013824 K072393 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.