Catalog Number

11097599

Brand Name

Atellica™ CH ASTP5P

Version/Model Number

11097599

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

K991576

Product Code

CIT

Product Code Name

Nadh oxidation/nad reduction, ast/sgot

Public Device Record Key

6f3e6ee3-e76d-4c88-a4bd-1814d3dfd801

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

December 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-