Catalog Number

-

Brand Name

Normal HbA2 Quik Column Control

Version/Model Number

5339

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2019

Issuing Agency

In HIBCC

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

K820787

Product Code

JCM

Product Code Name

CONTROL, HEMOGLOBIN, ABNORMAL

Public Device Record Key

fade2bf3-d596-4e93-b63a-94485a06f162

Public Version Date

November 28, 2019

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-