Catalog Number

40900

Brand Name

AlcoCheck

Version/Model Number

40900

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2019

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)

Yes

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

bfe6cf2f-77c8-4548-add6-9adb5221635d

Public Version Date

May 03, 2019

Public Version Number

4

DI Record Publish Date

February 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-