510(k) K023362

FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN by Fisher Diagnostics — Product Code GKP

K023362 is an FDA 510(k) premarket notification submitted by Fisher Diagnostics for the device "FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN". The FDA issued a decision of Substantially Equivalent on December 9, 2002. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Fisher Diagnostics has at least 10 other 510(k) clearances on record.