510(k) K023312

CONTROL PLASMA P by Dade Behring, Inc. — Product Code GGC

K023312 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "CONTROL PLASMA P". The FDA issued a decision of Substantially Equivalent on November 1, 2002. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.