Device Classification Name |
microbial nucleic acid storage and stabilization device
|
510(k) Number |
K201849 |
Device Name |
eNAT molecular collection and preservation medium |
Applicant |
Copan Italia S.p.A. |
Via F. Perotti 10 |
Brescia,
IT
25125
|
|
Applicant Contact |
Elena Simeonato |
Correspondent |
Copan Italia S.p.A. |
Via F. Perotti 10 |
Brescia,
IT
25125
|
|
Correspondent Contact |
Elena Simeonato |
Regulation Number | 866.2950
|
Classification Product Code |
|
Date Received | 07/06/2020 |
Decision Date | 09/17/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|