CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE

CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE is an FDA 510(k)-cleared medical device (K902083) 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 June 14, 1990. Regulation: 8.