
Beckman Instruments, Inc.
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SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR is an FDA 510(k)-cleared medical device (K971506) manufactured by Beckman Instruments, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 1997. Regulation: 8.