| Device Classification Name |
Instrumentation For Clinical Multiplex Test Systems
|
|---|
| 510(k) Number |
K080995 |
|---|
| Device Name |
MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM |
|---|
| Applicant |
| Affymetrix, Inc. |
| 3420 Central Expy. . |
|
Santa Clara,
CA
95051
|
|
| Applicant Contact |
MAUREEN J MENDE |
| Correspondent |
| Affymetrix, Inc. |
| 3420 Central Expy. . |
|
Santa Clara,
CA
95051
|
|
| Correspondent Contact |
MAUREEN J MENDE |
| Regulation Number | 862.2570 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/07/2008 |
|---|
| Decision Date | 07/30/2008 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Clinical Chemistry
|
|---|
| 510k Review Panel |
Clinical Chemistry
|
|---|
| Statement |
Statement
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|