Device Classification Name |
Lactoferrin, Antigen, Antiserum, Control
|
510(k) Number |
K934473 |
Device Name |
LACTOFERRIN MICROASSAY SYSTEM |
Applicant |
TOUCH SCIENTIFIC, INC. |
3209 GRESHAM LAKE RD. |
SUITE 112 |
RALEIGH,
NC
27615
|
|
Applicant Contact |
PIERCE R YOUNGBAR |
Correspondent |
TOUCH SCIENTIFIC, INC. |
3209 GRESHAM LAKE RD. |
SUITE 112 |
RALEIGH,
NC
27615
|
|
Correspondent Contact |
PIERCE R YOUNGBAR |
Regulation Number | 866.5570
|
Classification Product Code |
|
Date Received | 09/14/1993 |
Decision Date | 12/03/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|