
Heraeus Kulzer, Inc.
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TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) is an FDA 510(k)-cleared medical device (K930685) manufactured by Heraeus Kulzer, 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 June 21, 1993. Regulation: 8.