
Em Diagnostic Systems, Inc.
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IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R is an FDA 510(k)-cleared medical device (K930166) manufactured by Em Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 20, 1993. Regulation: 8.