Device Classification Name |
anti-dna indirect immunofluorescent solid phase
|
510(k) Number |
K231616 |
Device Name |
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine |
Applicant |
ZEUS Scientific |
200 Evans Way |
Branchburg,
NJ
08876
|
|
Applicant Contact |
Mark Kopnitsky |
Correspondent |
ZEUS Scientific |
200 Evans Way |
Branchburg,
NJ
08876
|
|
Correspondent Contact |
Mark Kopnitsky |
Regulation Number | 866.5100
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/02/2023 |
Decision Date | 08/31/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|