RUBELLA VIRUS ANTIGENS & CONTROLS

Antigen, Cf (including Cf Control), Rubella

ORION DIAGNOSTICA, INC.

The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Rubella Virus Antigens & Controls.

Pre-market Notification Details

Device IDK802937
510k NumberK802937
Device Name:RUBELLA VIRUS ANTIGENS & CONTROLS
ClassificationAntigen, Cf (including Cf Control), Rubella
Applicant ORION DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGON  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-19
Decision Date1980-12-31

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