510(k) K822799

STREPTACOCCUS CO-AGGLUTINATION KIT by American Scientific Products — Product Code GTP

K822799 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "STREPTACOCCUS CO-AGGLUTINATION KIT". The FDA issued a decision of Substantially Equivalent on December 19, 1982. The device falls under product code GTP (Exoenzymes, Multiple, Streptococcal), a Class I device regulated under 21 CFR 866.3720. American Scientific Products has at least 10 other 510(k) clearances on record.