510(k) K935748

ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT by Ortho Diagnostic Systems, Inc. — Product Code GJS

K935748 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT". The FDA issued a decision of Substantially Equivalent on Apr 26, 1995. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.