Device Classification Name |
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
|
510(k) Number |
K001900 |
Device Name |
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST |
Applicant |
HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. |
WEST SACRAMENTO,
CA
95691 -6221
|
|
Applicant Contact |
VIRGINIA CAPPEL |
Correspondent |
HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. |
WEST SACRAMENTO,
CA
95691 -6221
|
|
Correspondent Contact |
VIRGINIA CAPPEL |
Regulation Number | 866.5100
|
Classification Product Code |
|
Date Received | 06/22/2000 |
Decision Date | 09/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|