510(k) K043451

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR by Hyphen Biomed — Product Code GGN

K043451 is an FDA 510(k) premarket notification submitted by Hyphen Biomed for the device "BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR". The FDA issued a decision of Substantially Equivalent on March 17, 2005. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Hyphen Biomed has at least 5 other 510(k) clearances on record.