Device Classification Name |
instrumentation for clinical multiplex test systems
|
De Novo Number |
DEN040012 |
510(K) Number |
K042279
|
Device Name |
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM |
Requester |
affymetrix, inc. |
3380 central expressway |
santa clara,
CA
95051
|
|
Contact |
robert lipshutz |
|
Regulation Number | 862.2570
|
Classification Product Code |
|
Date Received | 11/03/2004 |
Decision Date | 12/23/2004 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Toxicology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|