510(k) K823131

KOAGULAB 40-A AUTOMATED COAGULATION SYS by Ortho Diagnostic Systems, Inc. — Product Code KQG

K823131 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "KOAGULAB 40-A AUTOMATED COAGULATION SYS". The FDA issued a decision of Substantially Equivalent on December 9, 1982. The device falls under product code KQG (Instrument, Coagulation), a Class II device regulated under 21 CFR 864.5400. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.