
Streck Laboratories, Inc.
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PLATELET-CHEX-HUMAN is an FDA 510(k)-cleared medical device (K770020) manufactured by Streck Laboratories, 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 February 15, 1977. Regulation: 8.