
Intl. Immunoassay Laboratories, Inc.
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EMBRITROL CK-MB CONTROLS is an FDA 510(k)-cleared medical device (K812671) manufactured by Intl. Immunoassay Laboratories, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 1, 1981. Regulation: 8.