
Bio-Chem Laboratory Systems, Inc.
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AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT is an FDA 510(k)-cleared medical device (K926563) manufactured by Bio-Chem Laboratory Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 1993. Regulation: 8.