Catalog Number

SK157-20

Brand Name

Iron

Version/Model Number

SK157-20

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

K973933

Product Code

JIY

Product Code Name

Photometric method, iron (non-heme)

Public Device Record Key

d0024812-f462-49b4-aac2-6a898b4d7880

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-