Device Classification Name |
reagent, borrelia serological reagent
|
510(k) Number |
K191240 |
Device Name |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System |
Applicant |
ZEUS Scientific Inc. |
P.O. BOX 38 |
Raritan,
NJ
08869
|
|
Applicant Contact |
Mark J. Kopnitsky |
Correspondent |
ZEUS Scientific Inc. |
P.O. BOX 38 |
Raritan,
NJ
08869
|
|
Correspondent Contact |
Mark J. Kopnitsky |
Regulation Number | 866.3830
|
Classification Product Code |
|
Date Received | 05/08/2019 |
Decision Date | 07/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|