Catalog Number

40900

Brand Name

AlcoCheck

Version/Model Number

40900

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111206

Product Code

DIC

Product Code Name

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Public Device Record Key

815dc422-3fea-496b-b166-428144a1c93a

Public Version Date

May 10, 2019

Public Version Number

1

DI Record Publish Date

May 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-