510(k) K852512

THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT by Pacific Hemostasis — Product Code GHH

K852512 is an FDA 510(k) premarket notification submitted by Pacific Hemostasis for the device "THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT". The FDA issued a decision of Substantially Equivalent on September 17, 1985. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Pacific Hemostasis has at least 10 other 510(k) clearances on record.