510(k) K921745

HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO by Hybritech, Inc. — Product Code JFH

K921745 is an FDA 510(k) premarket notification submitted by Hybritech, Inc. for the device "HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO". The FDA issued a decision of Substantially Equivalent on July 30, 1992. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Hybritech, Inc. has at least 10 other 510(k) clearances on record.