Catalog Number

-

Brand Name

CURO A1c

Version/Model Number

CURO A1c

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082275,K082275

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

713cbfd6-b3ad-435a-a582-e72a33155a67

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

April 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-