
Roche Diagnostic Systems, Inc.
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ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P is an FDA 510(k)-cleared medical device (K952337) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 1996. Regulation: 8.