Device Classification Name |
antibodies, gliadin
|
510(k) Number |
K002359 |
Device Name |
MDI GLIADIN G TEST |
Applicant |
MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 |
TUSTIN,
CA
92780 -7033
|
|
Applicant Contact |
MEHDI ALEM |
Correspondent |
MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 |
TUSTIN,
CA
92780 -7033
|
|
Correspondent Contact |
MEHDI ALEM |
Regulation Number | 866.5750
|
Classification Product Code |
|
Date Received | 08/02/2000 |
Decision Date | 10/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|