Device Classification Name |
high throughput dna sequence analyzer
|
De Novo Number |
DEN130011 |
510(K) Number |
K123989
|
Device Name |
ILLUMINA MISEQDX PLATFORM |
Requester |
illumina, inc. |
5200 illumina way |
san diego,
CA
92122
|
|
Contact |
leanne m kiviharju |
|
Regulation Number | 862.2265
|
Classification Product Code |
|
Date Received | 09/23/2013 |
Decision Date | 11/19/2013 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Clinical Chemistry
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|