
Anco Medical Reagents & Assoc.
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SICKLE-HEME A/S CONTROLS & A/A CONTROL is an FDA 510(k)-cleared medical device (K831871) manufactured by Anco Medical Reagents & Assoc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 1983. Regulation: 8.