Catalog Number

-

Brand Name

CURO L7 Lipid Test Strip - Lipid Profile

Version/Model Number

99LS10-2

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

K160282,K160282

Product Code

CHH

Product Code Name

Enzymatic Esterase--Oxidase, Cholesterol

Public Device Record Key

00d7c67e-d212-4e0d-9b68-4c83e74253e0

Public Version Date

April 29, 2020

Public Version Number

1

DI Record Publish Date

April 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-