Device Classification Name |
system, test, anticardiolipin immunological
|
510(k) Number |
K120817 |
Device Name |
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA |
Applicant |
INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. |
SAN DIEGO,
CA
92131 -1638
|
|
Applicant Contact |
ROSANNA KEIVENS |
Correspondent |
INOVA DIAGNOSTICS, INC. |
9900 OLD GROVE RD. |
SAN DIEGO,
CA
92131 -1638
|
|
Correspondent Contact |
ROSANNA KEIVENS |
Regulation Number | 866.5660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/19/2012 |
Decision Date | 02/26/2013 |
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
|
|
|