
Intl. Immunoassay Laboratories, Inc.
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125I QUICK-MB TEST KIT FOR QUANTITATION is an FDA 510(k)-cleared medical device (K821964) manufactured by Intl. Immunoassay Laboratories, 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 July 21, 1982. Regulation: 8.