
Emd Chemicals, Inc.
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ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& is an FDA 510(k)-cleared medical device (K823402) manufactured by Emd Chemicals, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 25, 1982. Regulation: 8.