Catalog Number

08H5901

Brand Name

CELL-DYN

Version/Model Number

08H59-01

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

K901875

Product Code

JCN

Product Code Name

CONTROL, CELL COUNTER, NORMAL AND ABNORMAL

Public Device Record Key

beb1f23c-88d4-4b73-ba07-ad19bc3e78aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-