Catalog Number

3L-10-16003A

Brand Name

GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil)

Version/Model Number

3L-10-16003A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 13, 2016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113307

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

06b04728-c9d6-4981-bc73-5f5a4fc2578c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-