
Helena Laboratories
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REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 is an FDA 510(k)-cleared medical device (K931465) manufactured by Helena Laboratories. 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 5, 1993. Regulation: 8.