Device Classification Name |
reagent, borrelia serological reagent
|
510(k) Number |
K080012 |
Device Name |
PLATELIA LYME IGG ASSAY |
Applicant |
BIO-RAD |
163 CABOT ST. |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
BIO-RAD |
163 CABOT ST. |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 866.3830
|
Classification Product Code |
|
Date Received | 01/03/2008 |
Decision Date | 05/08/2008 |
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
|
|
|