Duns Number:227530649
Device Description: A Glucose test system is a device intended for the quantitative in vitro determination of A Glucose test system is a device intended for the quantitative in vitro determination of glucose concentration in serum, plasma and urine
Catalog Number
GL1611
Brand Name
GLUC-HK
Version/Model Number
GL1611
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K953210
Product Code
CFR
Product Code Name
Hexokinase, Glucose
Public Device Record Key
fd3bc038-c7b9-4f14-a4fb-ff8d18ffbb75
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |