
Isolab, Inc.
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QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY is an FDA 510(k)-cleared medical device (K942276) manufactured by Isolab, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 19, 1995. Regulation: 8.