510(k) K821408

PHENOBARBITAL FLUORESCENT IMMUNO by American Diagnostic Corp. — Product Code LET

K821408 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "PHENOBARBITAL FLUORESCENT IMMUNO". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code LET (Fluorescent Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.