ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

PHADIA US INC.

The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia M2; Immunoassay, Positive Control 100, Positive Control 250.

Pre-market Notification Details

Device IDK141375
510k NumberK141375
Device Name:ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
ClassificationAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant PHADIA US INC. MUNZINGER STRASSE 7 Freiburg Im Breisgau,  DE 79111
ContactManuela Constanze Hog
CorrespondentManuela Constanze Hog
PHADIA US INC. MUNZINGER STRASSE 7 Freiburg Im Breisgau,  DE 79111
Product CodeDBM  
CFR Regulation Number866.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-27
Decision Date2015-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066010908 K141375 000
07333066014326 K141375 000
07333066014319 K141375 000

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