Catalog Number

-

Brand Name

n/a

Version/Model Number

662-7000-34A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182085

Product Code

JWY

Product Code Name

Manual antimicrobial susceptibility test systems

Public Device Record Key

b6c6aab2-0253-47bb-ba13-fca36997cee6

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

October 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-