Catalog Number

-

Brand Name

CURO L5 Total Cholesterol Strips

Version/Model Number

CURO L5 Total Cholesterol Strips

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130295,K130295

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

3bd9e660-1303-4115-8589-7ce543467690

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

April 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-