NEW YORK ─ The US Food and Drug Administration in January granted 510(k) clearances for tests from Siemens Healthineers, Roche, and Abbott, according to the agency's website.
Siemens Healthineers obtained clearance for its Immulite, Immulite 1000, and Immulite 2000 analyzers and enzyme-labeled chemiluminescent competitive immunoassays for the quantitative measurement of cortisol in serum and to clinically assess adrenal status.