
The Upjohn Co.
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CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT is an FDA 510(k)-cleared medical device (K810853) manufactured by The Upjohn Co.. 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 28, 1981. Regulation: 8.