Catalog Number

997-60901

Brand Name

uTASWako AFP-L3 Calibrator Set

Version/Model Number

997-60901

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

K100464,K100464

Product Code

JIT

Product Code Name

Calibrator, Secondary

Public Device Record Key

fc3eab7e-14ab-46a8-9a50-fbe420d989ec

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

October 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-