Device Classification Name |
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
|
510(k) Number |
K981306 |
Device Name |
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM |
Applicant |
DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. |
MIAMI,
FL
33127
|
|
Applicant Contact |
LYNNE STIRLING |
Correspondent |
DIAMEDIX CORP. |
2140 NORTH MIAMI AVE. |
MIAMI,
FL
33127
|
|
Correspondent Contact |
LYNNE STIRLING |
Regulation Number | 866.3305
|
Classification Product Code |
|
Date Received | 04/10/1998 |
Decision Date | 09/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|