Catalog Number

308151

Brand Name

Stop Solution (Allergy)

Version/Model Number

308151

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

Yes

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

K941278

Product Code

DHB

Product Code Name

System, Test, Radioallergosorbent (Rast) Immunological

Public Device Record Key

c0cbae30-194d-49be-ab36-4bcdf4b6c3be

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-