
Roche Diagnostic Systems, Inc.
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MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR is an FDA 510(k)-cleared medical device (K871680) 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 June 7, 1987. Regulation: 8.