
Biowhittaker Molecular Applications, Inc.
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RHEUMELISA II JO-1 ANTIBODY TEST KIT is an FDA 510(k)-cleared medical device (K930757) manufactured by Biowhittaker Molecular Applications, 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 March 25, 1993. Regulation: 8.