
Louisville Apl Diagnostics, Inc.
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ACL/APS FACS KIT is an FDA 510(k)-cleared medical device (K984102) manufactured by Louisville Apl Diagnostics, 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 17, 1999. Regulation: 8.