QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

System, Test, Rheumatoid Factor

Inova Diagnostics, Inc.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Rf Igm Reagents, Quanta Flash Rf Iga Reagents.

Pre-market Notification Details

Device IDK190088
510k NumberK190088
Device Name:QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
ClassificationSystem, Test, Rheumatoid Factor
Applicant Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego,  CA  92131 -1638
ContactRoger Albesa
CorrespondentRoger Albesa
Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego,  CA  92131 -1638
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-17
Decision Date2019-04-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950845249 K190088 000
08426950835189 K190088 000

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