Catalog Number

-

Brand Name

DRI Salicylate Calibrator Kit

Version/Model Number

0980

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2016

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K961131

Product Code

DKJ

Product Code Name

Colorimetry, Salicylate

Public Device Record Key

b27a8bef-ba0e-4ef0-a521-a04da4d7d8ec

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-