Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K232308 |
Device Name |
Monarch Blood Collection Set |
Applicant |
The Monarch Company |
4000 Eagle Point Corporate Drive |
Birmingham,
AL
35242
|
|
Applicant Contact |
Jonathan Trawick |
Correspondent |
The Monarch Company |
4000 Eagle Point Corporate Drive |
Birmingham,
AL
35242
|
|
Correspondent Contact |
Pooja Kannam |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 08/02/2023 |
Decision Date | 12/04/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|