Device Classification Name |
Extractable Antinuclear Antibody, Antigen And Control
|
510(k) Number |
K970218 |
Device Name |
IS-ANTI-SSA TEST SYSTEM |
Applicant |
DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. |
MIAMI,
FL
33127
|
|
Applicant Contact |
LYNNE STIRLING, PH.D. |
Correspondent |
DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. |
MIAMI,
FL
33127
|
|
Correspondent Contact |
LYNNE STIRLING, PH.D. |
Regulation Number | 866.5100
|
Classification Product Code |
|
Date Received | 01/21/1997 |
Decision Date | 04/08/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|