Catalog Number

3L-10-14003T

Brand Name

GlucoLeader Enhance Blood Glucose foil packed test strip

Version/Model Number

3L-10-14003T

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

13148079-0e20-4020-9595-fedbba73d12c

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Package DI Number

04711200723076

Quantity per Package

240

Contains DI Package

04711200721843

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Foil