
Theratest Laboratories, Inc.
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THERATEST EL-ANA PROFILES TEST SYSTEM is an FDA 510(k)-cleared medical device (K950716) manufactured by Theratest Laboratories, 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 September 25, 1995. Regulation: 8.