
Diagnostic Systems Laboratories, Inc.
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AXSYM INTACT PTH, MODEL 2G06 is an FDA 510(k)-cleared medical device (K020945) manufactured by Diagnostic Systems Laboratories, 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 May 30, 2002. Regulation: 8.