
Beckman Instruments, Inc.
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IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT is an FDA 510(k)-cleared medical device (K965035) manufactured by Beckman Instruments, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 16, 1997. Regulation: 8.