Catalog Number

-

Brand Name

TysonBio AC500 Control Solution (Level 1)

Version/Model Number

AC500

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123087,K123087,K123087,K123087

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

5c9899d2-6f74-4291-b7de-d0fd0b458b8c

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

April 15, 2020

Package DI Number

14719869703146

Quantity per Package

100

Contains DI Package

04719869703149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-