Duns Number:064608573
Device Description: Creatine Kinase Liquid (CK_L) Atellica CH - RGT 664T
Catalog Number
11097640
Brand Name
Atellica CH CK_L
Version/Model Number
11097640
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
K160724
Product Code
CGS
Product Code Name
NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
Public Device Record Key
ce83124e-13dc-4f00-8a6e-d9774b5334cc
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
December 21, 2017
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |