510(k) K083729

HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN by Aniara Diagnostica, LLC — Product Code GGW

K083729 is an FDA 510(k) premarket notification submitted by Aniara Diagnostica, LLC for the device "HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN". The FDA issued a decision of Substantially Equivalent on May 8, 2009. The device falls under product code GGW (Test, Time, Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925.