RA LATEX TEST

System, Test, Rheumatoid Factor

OXOID U.S.A., INC.

The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Ra Latex Test.

Pre-market Notification Details

Device IDK812972
510k NumberK812972
Device Name:RA LATEX TEST
ClassificationSystem, Test, Rheumatoid Factor
Applicant OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-23
Decision Date1981-11-06

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