Catalog Number

3K-01-16003F

Brand Name

PRECICHEK AutoCode AC300

Version/Model Number

3K-01-16003F

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

K120064,K120064

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

fba8769c-3166-4110-9aee-df2c4a487db4

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 2020

Package DI Number

00389154000846

Quantity per Package

60

Contains DI Package

04260236850985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT