
Alerchek, Inc.
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FLIPSCREEN (TM) TOTAL E IMMUNOASSAY is an FDA 510(k)-cleared medical device (K885307) manufactured by Alerchek, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 1989. Regulation: 8.