Device Classification Name |
antibodies, gliadin
|
510(k) Number |
K113863 |
Device Name |
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS |
Applicant |
INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. |
SAN DIEGO,
CA
92131 -1638
|
|
Applicant Contact |
GABRIELLA LAKOS |
Correspondent |
INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. |
SAN DIEGO,
CA
92131 -1638
|
|
Correspondent Contact |
GABRIELLA LAKOS |
Regulation Number | 866.5750
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/30/2011 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|