Device Classification Name |
culture media, non-propagating transport
|
510(k) Number |
K202531 |
Device Name |
Azer Scientific Universal Transport Medium |
Applicant |
Azer Scientific, Inc. |
701 Hemlock Road |
Morgantown,
PA
19543
|
|
Applicant Contact |
Autumn N. Tellup |
Correspondent |
Azer Scientific, Inc. |
44 Oxford Drive |
East Winsor,
NJ
08520
|
|
Correspondent Contact |
Katrina Fiedler |
Regulation Number | 866.2390
|
Classification Product Code |
|
Date Received | 09/01/2020 |
Decision Date | 04/11/2024 |
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
|
|
|