COBAS(R) CORE T3 EIA

COBAS(R) CORE T3 EIA is an FDA 510(k)-cleared medical device (K932608) manufactured by Roche Diagnostic Systems, Inc.. 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 December 2, 1993. Regulation: 8.