510(k) K000471

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT by Future Diagnostics B.V. — Product Code CEW

K000471 is an FDA 510(k) premarket notification submitted by Future Diagnostics B.V. for the device "FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT". The FDA issued a decision of Substantially Equivalent on April 11, 2000. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Future Diagnostics B.V. has at least 1 other 510(k) clearance on record.