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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCOBAS 4800 BRAF V600 MUTATION TEST
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP110020
Supplement NumberS003
Date Received12/12/2011
Decision Date09/04/2012
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change in the dna synthesizer instrument platform for certain vialed master mix and probe reagent components.
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