510(k) K812076

ANTI-GM & ANTI-KM TYPING SERUMS by Biotest-Serum-Institut — Product Code DGH

K812076 is an FDA 510(k) premarket notification submitted by Biotest-Serum-Institut for the device "ANTI-GM & ANTI-KM TYPING SERUMS". The FDA issued a decision of Substantially Equivalent on August 12, 1981. The device falls under product code DGH (Igd, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Biotest-Serum-Institut has at least 1 other 510(k) clearance on record.