
Biosite Incorporated
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TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS is an FDA 510(k)-cleared medical device (K030088) manufactured by Biosite Incorporated. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 16, 2003. Regulation: 8.