Catalog Number

3L-10-16003D

Brand Name

PRECICHEK AutoCode foil packed test strip

Version/Model Number

3L-10-16003D

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120064,K120064

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

d2e1d562-6e78-4514-ad1a-86cafa8511b0

Public Version Date

July 14, 2020

Public Version Number

1

DI Record Publish Date

July 06, 2020

Package DI Number

04260236851203

Quantity per Package

210

Contains DI Package

04260236850664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

FOIL