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Wallac, Inc.
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WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 is an FDA 510(k)-cleared medical device (DEN990008) manufactured by Wallac, Inc.. 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 14, 2000. Regulation: 8.