Device Classification Name |
Epstein-Barr Virus, Other
|
510(k) Number |
K062211 |
Device Name |
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM |
Applicant |
BIO-RAD LABORATORIES, INC. |
6565 185TH AVE., N.E. |
REDMOND,
WA
98052
|
|
Applicant Contact |
DAVID BHEND |
Correspondent |
BIO-RAD LABORATORIES, INC. |
6565 185TH AVE., N.E. |
REDMOND,
WA
98052
|
|
Correspondent Contact |
DAVID BHEND |
Regulation Number | 866.3235
|
Classification Product Code |
|
Date Received | 08/01/2006 |
Decision Date | 12/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|