
Beckman Instruments, Inc.
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ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 is an FDA 510(k)-cleared medical device (K974816) 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 February 19, 1998. Regulation: 8.