
General Biometrics, Inc.
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IMMUNOWELL TPO (MICROSOME) TEST is an FDA 510(k)-cleared medical device (K905486) manufactured by General Biometrics, 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 January 2, 1991. Regulation: 8.