
Technicon Instruments Corp.
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RA-1000 SYSTEM ADD'L ANALYTES PHASE III is an FDA 510(k)-cleared medical device (K820913) 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 May 2, 1982. Regulation: 8.