
Roche Diagnostics
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COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY is an FDA 510(k)-cleared medical device (K092603) 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 December 3, 2009. Regulation: 8.