
Johnson & Johnson Clinical Diagnostics, Inc.
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VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) is an FDA 510(k)-cleared medical device (K964982) 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 February 19, 1997. Regulation: 8.