Device Classification Name |
method, enzymatic, glucose (urinary, non-quantitative)
|
510(k) Number |
K193514 |
Device Name |
AUTION MAX AX-4060 Urinalysis System |
Applicant |
Arkray Inc. |
Yousuien-Nai, 59 Gansuin-Cho |
Kamigyo-ku,
JP
602-0008
|
|
Applicant Contact |
Hideko Kosaka |
Correspondent |
Arkray Factory USA Inc. |
5198 West 76th Street |
Minneapolis,
MN
55439
|
|
Correspondent Contact |
Daya Ranamukhaarachchi |
Regulation Number | 862.1340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/19/2019 |
Decision Date | 04/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|