
Bartels Immunodiagnostic Supplies, Inc.
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AMER. HISTO-ID SYS PRIMARY IGG S7920-11 is an FDA 510(k)-cleared medical device (K842329) manufactured by Bartels Immunodiagnostic Supplies, 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 August 1, 1984. Regulation: 8.