Duns Number:132528295
Device Description: D-10 Analytical Cartridge Hemoglobin A1c Program
Catalog Number
2200113
Brand Name
D-10
Version/Model Number
220-0113
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
K031043
Product Code
LCP
Product Code Name
ASSAY, GLYCOSYLATED HEMOGLOBIN
Public Device Record Key
70100a2a-a1ed-458b-b06f-d26e5727d4ea
Public Version Date
July 29, 2021
Public Version Number
7
DI Record Publish Date
September 12, 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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |