Device Classification Name |
method, enzymatic, glucose (urinary, non-quantitative)
|
510(k) Number |
K171083 |
Device Name |
iChemVELOCITY Automated Urine Chemistry System |
Applicant |
Iris Diagnostics, a Division of Iris International Inc |
9172 Eton Avenue |
Chatsworth,
CA
91311
|
|
Applicant Contact |
Nancy Nadler |
Correspondent |
Iris Diagnostics, a Division of Iris International Inc |
9172 Eton Avenue |
Chatsworth,
CA
91311
|
|
Correspondent Contact |
Nancy Nadler |
Regulation Number | 862.1340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/11/2017 |
Decision Date | 05/12/2017 |
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
|
|
|