Device Classification Name |
ige, antigen, antiserum, control
|
510(k) Number |
K991316 |
Device Name |
TOUCH TEAR IGE MICROASSAY KIT |
Applicant |
TOUCH SCIENTIFIC, INC. |
3209 GRESHAM LAKE RD. |
SUITE 112 |
RALEIGH,
NC
27615
|
|
Applicant Contact |
ALAN J TOUCH |
Correspondent |
TOUCH SCIENTIFIC, INC. |
3209 GRESHAM LAKE RD. |
SUITE 112 |
RALEIGH,
NC
27615
|
|
Correspondent Contact |
ALAN J TOUCH |
Regulation Number | 866.5510
|
Classification Product Code |
|
Date Received | 04/19/1999 |
Decision Date | 08/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|