510(k) K991101

COAG-A-MATE MAX by Organon Teknika Corp. — Product Code GKP

K991101 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "COAG-A-MATE MAX". The FDA issued a decision of Substantially Equivalent on June 1, 1999. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.