STREPTO-SEC TM

Antisera, All Groups, Streptococcus Spp.

ORGANON, INC.

The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Strepto-sec Tm.

Pre-market Notification Details

Device IDK801159
510k NumberK801159
Device Name:STREPTO-SEC TM
ClassificationAntisera, All Groups, Streptococcus Spp.
Applicant ORGANON, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-11
Decision Date1980-06-20

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