Catalog Number

-

Brand Name

SCS-1000 Calibrator

Version/Model Number

217685

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

K943268

Product Code

KSA

Product Code Name

CALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING

Public Device Record Key

19107cc3-45b1-4f47-b54f-8d5a53f98303

Public Version Date

September 18, 2018

Public Version Number

4

DI Record Publish Date

August 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-