510(k) K073367

HEMOSIL FIBRINOGEN-C by Instrumentation Laboratory CO — Product Code KQJ

K073367 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL FIBRINOGEN-C". The FDA issued a decision of Substantially Equivalent on December 27, 2007. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.