
Boehringer Mannheim Corp.
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CARDIAC T TROPONIN T RAPID ASSAY is an FDA 510(k)-cleared medical device (K964372) manufactured by Boehringer Mannheim Corp.. 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 February 9, 1997. Regulation: 8.