510(k) K231927

Elecsys PTH , Elecsys PTH STAT by Roche Diagnostics — Product Code CEW

K231927 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys PTH , Elecsys PTH STAT". The FDA issued a decision of Substantially Equivalent on March 22, 2024. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Roche Diagnostics has at least 10 other 510(k) clearances on record.