Device Classification Name |
lambda, antigen, antiserum, control
|
510(k) Number |
K140396 |
Device Name |
FREELITE HUMAN LAMBDA FREE KIT |
Applicant |
THE BINDING SITE GROUP, LTD. |
5889 OBDERLIN DR., STE 101 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
DOUG KURTH |
Correspondent |
THE BINDING SITE GROUP, LTD. |
5889 OBDERLIN DR., STE 101 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
DOUG KURTH |
Regulation Number | 866.5550
|
Classification Product Code |
|
Date Received | 02/18/2014 |
Decision Date | 04/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|