
Technicon Instruments Corp.
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TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) is an FDA 510(k)-cleared medical device (K874658) manufactured by Technicon Instruments Corp.. 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 December 17, 1987. Regulation: 8.