
Diagnostic Chemicals, Ltd. (Usa)
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CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 is an FDA 510(k)-cleared medical device (K880868) manufactured by Diagnostic Chemicals, Ltd. (Usa). 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 October 31, 1988. Regulation: 8.