
Beckman Instruments, Inc.
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IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS is an FDA 510(k)-cleared medical device (K963673) 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 February 3, 1997. Regulation: 8.