ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P

ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P is an FDA 510(k)-cleared medical device (K972721) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 5, 1997. Regulation: 8.