Device Classification Name |
electrode, ion specific, potassium
|
510(k) Number |
K200544 |
Device Name |
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ |
Applicant |
Diamond Diagnostics Inc. |
333 Fiske Street |
Holliston,
MA
01746
|
|
Applicant Contact |
Kathy Fisher |
Correspondent |
Diamond Diagnostics Inc. |
333 Fiske Street |
Holliston,
MA
01746
|
|
Correspondent Contact |
Kathy Fisher |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/03/2020 |
Decision Date | 10/01/2020 |
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
|
|
|