Device Classification Name |
Igg, Antigen, Antiserum, Control
|
510(k) Number |
K924197 |
Device Name |
ZORBA(TM) IGG REMOVAL REAGENT |
Applicant |
ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 |
RARITAN,
NJ
08869
|
|
Applicant Contact |
JOSEPH A ROSEBROCK |
Correspondent |
ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 |
RARITAN,
NJ
08869
|
|
Correspondent Contact |
JOSEPH A ROSEBROCK |
Regulation Number | 866.5510
|
Classification Product Code |
|
Date Received | 08/20/1992 |
Decision Date | 12/15/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|