Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions is an FDA 510(k)-cleared medical device (K253490) 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 February 11, 2026. Regulation: 8.