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Access Bio Incorporate
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CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN is an FDA 510(k)-cleared medical device (K051925) manufactured by Access Bio Incorporate. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2005. Regulation: 8.