Catalog Number

3L-10-120032

Brand Name

GlucoLeader Enhance Blood Glucose Test Strip(for PTA)

Version/Model Number

3L-10-120032

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

K032985,K032985

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

5d49e21c-37c7-4fa4-87d3-de0dd603fb6e

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Package DI Number

04711200723052

Quantity per Package

180

Contains DI Package

04711200721898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Foil