Catalog Number

-

Brand Name

microINR ® Meter

Version/Model Number

KTC0001AD

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

K201185,K201185

Product Code

GJS

Product Code Name

Test, Time, Prothrombin

Public Device Record Key

ca759c6d-cf55-4dd8-9459-a2a859e9e499

Public Version Date

July 06, 2021

Public Version Number

2

DI Record Publish Date

May 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-