
Hyland Therapeutic Div., Travenol Laboratories
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ALERT A,HDL-APOLIPOROTEIN A, TEST KIT is an FDA 510(k)-cleared medical device (K802610) manufactured by Hyland Therapeutic Div., Travenol Laboratories. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 1981. Regulation: 8.