510(k) K885113

IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL by Investigacion Farmaceutica S.A. DE C.V. — Product Code GSN

K885113 is an FDA 510(k) premarket notification submitted by Investigacion Farmaceutica S.A. DE C.V. for the device "IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code GSN (Antiserum, Positive And Negative Febrile Antigen Control Serum), a Class II device regulated under 21 CFR 866.3085. Investigacion Farmaceutica S.A. DE C.V. has at least 10 other 510(k) clearances on record.