
Miles Laboratories, Inc.
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CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) is an FDA 510(k)-cleared medical device (K873304) manufactured by Miles Laboratories, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 10, 1987. Regulation: 8.