510(k) K063232

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 by Biokit, S.A. — Product Code CEW

K063232 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01". The FDA issued a decision of Substantially Equivalent on June 19, 2007. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Biokit, S.A. has at least 10 other 510(k) clearances on record.