
Biochem Immunosystems (U.S.), Inc.
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PERSONALLAB AUTOMATED MICROPLATE ANALYZER is an FDA 510(k)-cleared medical device (K971761) manufactured by Biochem Immunosystems (U.S.), Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 21, 1997. Regulation: 8.