510(k) K940209

ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL by Ortho Diagnostic Systems, Inc. — Product Code GGN

K940209 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.