Duns Number:064608573
Device Description: Pancreatic Amylase (Pamy) Atellica CH - RGT 1720T
Catalog Number
11097622
Brand Name
Atellica CH PAmy
Version/Model Number
11097622
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
K971825
Product Code
JFJ
Product Code Name
CATALYTIC METHODS, AMYLASE
Public Device Record Key
64ad3949-b47a-4ed7-b0b7-f8deb60ee67a
Public Version Date
June 10, 2022
Public Version Number
6
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 |