510(k) K952557

TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS by Sigma Diagnostics, Inc. — Product Code CDP

K952557 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS". The FDA issued a decision of Substantially Equivalent on Jan 24, 1996. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.