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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.
 
Trade NameCOBAS 4800 BRAF V600 MUTATION TEST
Classification Namesomatic gene mutation detection system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP110020
Supplement NumberS002
Date Received09/29/2011
Decision Date10/26/2011
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to the filling and labeling equipment and location for certain vialed intermediate components. Your firm has proposed relocation to building 502 rooms 1f24 and 1f26 from building 502 rooms 1f23 and 1f31 for use of new equipment kugler linoline 120 filing and screw-capping line which includes the accraply 4000 and 35t labeling machines.
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