510(k) K822298

DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI by Nuclear Medical Laboratories, Inc. — Product Code JFH

K822298 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI". The FDA issued a decision of Substantially Equivalent on September 2, 1982. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Nuclear Medical Laboratories, Inc. has at least 10 other 510(k) clearances on record.