Device Classification Name |
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
|
510(k) Number |
K120169 |
Device Name |
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT |
Applicant |
GRIFOLS USA, LLC |
482 CHERRY LANE RD. |
EAST STROUDSBURG,
PA
18301
|
|
Applicant Contact |
Gary Lehnus |
Correspondent |
GRIFOLS USA, LLC |
482 CHERRY LANE RD. |
EAST STROUDSBURG,
PA
18301
|
|
Correspondent Contact |
Gary Lehnus |
Regulation Number | 866.5510
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/19/2012 |
Decision Date | 08/24/2012 |
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
|
|
|