510(k) K170864

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit by Maine Standards Company, LLC — Product Code GGN

K170864 is an FDA 510(k) premarket notification submitted by Maine Standards Company, LLC for the device "VALIDATE D-Dimer Calibration Verification / Linearity Test Kit". The FDA issued a decision of Substantially Equivalent on June 21, 2017. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Maine Standards Company, LLC has at least 6 other 510(k) clearances on record.