
Beckman Instruments, Inc.
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ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 is an FDA 510(k)-cleared medical device (K981354) manufactured by Beckman Instruments, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 1998. Regulation: 8.