Duns Number:052423787
Device Description: ELITechGroup Inc CHLOROCHEK Standard Solution is an aqueous solution used to conditioning ELITechGroup Inc CHLOROCHEK Standard Solution is an aqueous solution used to conditioning or check the performance of ChloroChek Chloridometer by qualified personnel.
Catalog Number
-
Brand Name
ChloroChek® Standard Solution, 100 mmol/L, 10x1mL
Version/Model Number
SS-251
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121823
Product Code
JIS
Product Code Name
Calibrator, Primary
Public Device Record Key
151ad4ae-fdde-4119-af50-0ab999c63d6b
Public Version Date
March 01, 2021
Public Version Number
1
DI Record Publish Date
February 19, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |