Elecsys PTH , Elecsys PTH STAT

Elecsys PTH , Elecsys PTH STAT is an FDA 510(k)-cleared medical device (K231927) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2024. Regulation: 8.