
Johnson & Johnson Clinical Diagnostics, Inc.
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VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) is an FDA 510(k)-cleared medical device (K973030) manufactured by Johnson & Johnson Clinical Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 3, 1997. Regulation: 8.