Exoenzymes, Multiple, Streptococcal

FDA product code GTP · Class I (low risk) · 21 CFR 866.3720 · Microbiology

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K860041Strep D FluorGTP · Traditional Bio Spec, Inc.01/24/1986SE
K833738Leap Strep Test KitGTP · Traditional Cooper Biomedical, Inc.12/27/1983SE
K822799Streptacoccus Co-Agglutination KitGTP · Traditional American Scientific Products12/19/1982SE