510(k) K020840

VITAL SCIENTIFIC PT WITH CALCIUM by Vital Scientific N.V. — Product Code GJS

K020840 is an FDA 510(k) premarket notification submitted by Vital Scientific N.V. for the device "VITAL SCIENTIFIC PT WITH CALCIUM". The FDA issued a decision of Substantially Equivalent on May 15, 2002. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Vital Scientific N.V. has at least 4 other 510(k) clearances on record.