Device Classification Name |
Antinuclear Antibody, Antigen, Control
|
510(k) Number |
K954723 |
Device Name |
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT |
Applicant |
HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. |
WEST SACRAMENTO,
CA
95691 -6221
|
|
Applicant Contact |
VIRGINIA L CAPPEL |
Correspondent |
HELIX DIAGNOSTICS, INC. |
3148 INDUSTRIAL BLVD. |
WEST SACRAMENTO,
CA
95691 -6221
|
|
Correspondent Contact |
VIRGINIA L CAPPEL |
Regulation Number | 866.5100
|
Classification Product Code |
|
Date Received | 10/13/1995 |
Decision Date | 12/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|