Catalog Number

10220-4

Brand Name

Mg Reagent Kit

Version/Model Number

10220-4

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

K080810

Product Code

JGJ

Product Code Name

Photometric Method, Magnesium

Public Device Record Key

bcdc9dcd-091c-4e5d-b90d-fe5a099b05b9

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-