
Perkinelmer, Inc.
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NEONATAL BIOTINIDASE KIT, MODEL 3018 is an FDA 510(k)-cleared medical device (K090123) manufactured by Perkinelmer, 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 March 4, 2010. Regulation: 8.