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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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