510(k) K854490

IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES by American Micro Scan — Product Code GRP

K854490 is an FDA 510(k) premarket notification submitted by American Micro Scan for the device "IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES". The FDA issued a decision of Substantially Equivalent on December 27, 1985. The device falls under product code GRP (Antisera, All Types, H. Influenza), a Class II device regulated under 21 CFR 866.3300. American Micro Scan has at least 10 other 510(k) clearances on record.