
Roche Diagnostic Systems, Inc.
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COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS is an FDA 510(k)-cleared medical device (K945523) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 1995. Regulation: 8.