Duns Number:315028860
Catalog Number
4745914001
Brand Name
cobas c 501 Module
Version/Model Number
4745914001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060373
Product Code
JJF
Product Code Name
ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE
Public Device Record Key
b52381ec-e82f-4181-b6dc-83f48e269cf6
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
September 20, 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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 760 |
| 3 | A medical device with high risk that requires premarket approval | 63 |
| U | Unclassified | 4 |