FDA PMA Number P140023, COBAS KRAS MUTATION TEST

FDA PMA Number P140023, COBAS KRAS MUTATION TEST

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PMA Number: P140023
Device: COBAS KRAS MUTATION TEST
Generic Name: Somatic gene mutation detection system
Manufacturer: Roche Molecular Systems, Inc.
Product Code: OWD
Date Received: 10/23/2014
Decision Date: 05/07/2015
Notice Date: 05/18/2015

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