
Hypoguard USA, Inc.
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DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) is an FDA 510(k)-cleared medical device (K033851) manufactured by Hypoguard USA, 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 1, 2004. Regulation: 8.