Image Navigator By Immuno Concepts

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Immuno Concepts, NA, Ltd.

The following data is part of a premarket notification filed by Immuno Concepts, Na, Ltd. with the FDA for Image Navigator By Immuno Concepts.

Pre-market Notification Details

Device IDK160265
510k NumberK160265
Device Name:Image Navigator By Immuno Concepts
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant Immuno Concepts, NA, Ltd. 9825 Goethe Road; Suite 350 Sacramento,  CA  95827
ContactEric S. Hoy
CorrespondentEric S. Hoy
Immuno Concepts, NA, Ltd. 9825 Goethe Road; Suite 350 Sacramento,  CA  95827
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-02
Decision Date2016-06-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M749IN2201 K160265 000
M749IN1101 K160265 000
M74900IN2201 K160265 000
M74900IN1101 K160265 000

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