Catalog Number

SK252-20

Brand Name

Microalbumin

Version/Model Number

SK252-20

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

K051191

Product Code

DCF

Product Code Name

ALBUMIN, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

8b137e01-43ad-4f4b-9cd3-8915bb2a649a

Public Version Date

October 10, 2019

Public Version Number

1

DI Record Publish Date

October 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-