
Syn-Kit, Inc.
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GESTE FOLLOW KIT DETERM. OF HPL is an FDA 510(k)-cleared medical device (K802454) manufactured by Syn-Kit, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 1980. Regulation: 8.