
Alpkem Corp.
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T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL is an FDA 510(k)-cleared medical device (K852008) manufactured by Alpkem 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 May 29, 1985. Regulation: 8.