Catalog Number

-

Brand Name

plt-CHECK

Version/Model Number

200-4004-1

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

K960557

Product Code

JPK

Product Code Name

MIXTURE, HEMATOLOGY QUALITY CONTROL

Public Device Record Key

57d5c0bf-b87d-4e29-aef0-955d28cec805

Public Version Date

September 18, 2018

Public Version Number

4

DI Record Publish Date

October 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-