Device Classification Name |
kappa, antigen, antiserum, control
|
510(k) Number |
K070900 |
Device Name |
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT |
Applicant |
THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 |
2425 WEST OLYMPIC BOULEVARD |
SANTA MONICA,
CA
90404
|
|
Applicant Contact |
JAY H GELLER |
Correspondent |
THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 |
2425 WEST OLYMPIC BOULEVARD |
SANTA MONICA,
CA
90404
|
|
Correspondent Contact |
JAY H GELLER |
Regulation Number | 866.5550
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/02/2007 |
Decision Date | 11/30/2007 |
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
|
|
|