Device Classification Name |
autoantibodies, endomysial(tissue transglutaminase)
|
510(k) Number |
K094060 |
Device Name |
QUANTA FLASH H-TTG IGA |
Applicant |
INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. |
SAN DIEGO,
CA
92131 -1638
|
|
Applicant Contact |
TANA KEIVENS |
Correspondent |
INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. |
SAN DIEGO,
CA
92131 -1638
|
|
Correspondent Contact |
TANA KEIVENS |
Regulation Number | 866.5660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/31/2009 |
Decision Date | 10/13/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|