
Coulter Electronics, Inc.
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ASSAY, AMPHET. NDC#11711-0127-1 COULTER is an FDA 510(k)-cleared medical device (K760196) manufactured by Coulter Electronics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 1976. Regulation: 8.