Duns Number:600039072
Device Description: Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing.
Catalog Number
-
Brand Name
Dario Glucose Control Solution
Version/Model Number
1054-05
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150817
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
86447f38-c7af-4da6-ae6b-153d35500e1f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 25, 2018
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |