Duns Number:427395277
Device Description: Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a dev Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Catalog Number
5202
Brand Name
K ELECTRODE, ISE MODULE
Version/Model Number
K+ Electrode
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101741,K101741
Product Code
CEM
Product Code Name
Electrode, Ion Specific, Potassium
Public Device Record Key
c9ef5ee3-6062-4ded-9369-5d0014614655
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 06, 2016
Package DI Number
15999883586690
Quantity per Package
1
Contains DI Package
05999883586693
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |