
Roche Molecular Systems, Inc.
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AMPLICHIP CYP450 TEST, MODEL 04381866190 is an FDA 510(k)-cleared medical device (DEN040011) manufactured by Roche Molecular Systems, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 2004. Regulation: 8.