Catalog Number

490 4+4

Brand Name

Chrono-log

Version/Model Number

490 4+4

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

K161329

Product Code

JOZ

Product Code Name

System, Automated Platelet Aggregation

Public Device Record Key

2052c122-7a5f-414e-82f7-1b04d17175f9

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

December 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-