Catalog Number

SR00TS

Brand Name

Research and Diagnostic Systems

Version/Model Number

SR00TS

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

K991876

Product Code

JPK

Product Code Name

Mixture, Hematology Quality Control

Public Device Record Key

74baf16a-6e5d-4f08-a8c7-1bb30e26aaba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-