510(k) K822229

PRIMIDONE FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code LFT

K822229 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "PRIMIDONE FLUORESCENT IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on August 12, 1982. The device falls under product code LFT (Fluorescent Immunoassay, Primidone), a Class II device regulated under 21 CFR 862.3680. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.