Catalog Number

00003510000

Brand Name

Urine Standard, 100 Na 100K

Version/Model Number

00003510000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2019

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

K823480

Product Code

JJO

Product Code Name

FLAME EMISSION PHOTOMETER FOR CLINICAL USE

Public Device Record Key

79ad6931-eb6a-4808-9ee1-e7e5f674ce63

Public Version Date

July 13, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-