Duns Number:064608573
Device Description: Clinitek Atlas® 10 Reagent PAK for Urine Chemistry for use with the Clinitek Atlas® Urine Clinitek Atlas® 10 Reagent PAK for Urine Chemistry for use with the Clinitek Atlas® Urine Chemistry Analyzer
Catalog Number
5017
Brand Name
Clinitek Atlas® 10 Reagent PAK for Urine Chemistry
Version/Model Number
10311120
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
K932674
Product Code
KQO
Product Code Name
AUTOMATED URINALYSIS SYSTEM
Public Device Record Key
1541c3d6-5475-4dea-a29e-2852d2817aba
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 24, 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 | 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 |