Catalog Number

IR-500

Brand Name

Synermed®

Version/Model Number

IR-500

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K935662

Product Code

JIQ

Product Code Name

Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

Public Device Record Key

e66d87da-27a0-4af7-b59e-d27ad4a7e7bf

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-