Duns Number:004135503
Device Description: Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of readings Control Solution to apply to Blood Glucose Test Strips to verify the accuracy of readings from a Blood Glucose meter and/or Test Strips.
Catalog Number
98302-0001-03
Brand Name
Clever Choice
Version/Model Number
Control
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
fa204ad2-49f7-44a7-9117-17cd90330430
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 07, 2016
Package DI Number
10898302001033
Quantity per Package
100
Contains DI Package
00898302001036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |