
Diagnostic Reagent Tech.
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NEW ALLERG. COATED MICROFILTER WELL STRI is an FDA 510(k)-cleared medical device (K843302) manufactured by Diagnostic Reagent Tech.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 1984. Regulation: 8.