
Mallinckrodt Critical Care
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SPAC TM T3 UPTAKE KIT is an FDA 510(k)-cleared medical device (K770033) manufactured by Mallinckrodt Critical Care. 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 6, 1977. Regulation: 8.