510(k) K813542

TOBRAMYCIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code LCR

K813542 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "TOBRAMYCIN FLUORESCENT IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 12, 1982. The device falls under product code LCR (Fluorescent Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.