Catalog Number

3S-01-1400333

Brand Name

GlucoLeader Enhance Blood Glucose Test Strip(for AF-SSA)

Version/Model Number

3S-01-1400333

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

3377d1ea-7b4d-48de-b3ee-65f58cb0cedc

Public Version Date

January 13, 2021

Public Version Number

1

DI Record Publish Date

January 05, 2021

Package DI Number

04711200723038

Quantity per Package

288

Contains DI Package

04711200721249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-