Catalog Number

123001

Brand Name

HemoCue® WBC Analyzer

Version/Model Number

123001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071652

Product Code

GKL

Product Code Name

Counter, Cell, Automated (Particle Counter)

Public Device Record Key

dd415ab7-713e-4045-a943-39ca31281462

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

May 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-