Catalog Number

700-3375

Brand Name

iQ200

Version/Model Number

Elite Plus (US) (2008 Version) (NA)

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

K022774

Product Code

KQO

Product Code Name

Automated Urinalysis System

Public Device Record Key

16f1ebc6-8b08-426e-9fd7-3345e1967c7c

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-