510(k) K935598

PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 by Clinical Controls, Inc. — Product Code GIL

K935598 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code GIL (Plasma, Fibrinogen Control), a Class II device regulated under 21 CFR 864.7340. Clinical Controls, Inc. has at least 10 other 510(k) clearances on record.