Catalog Number

-

Brand Name

Simplexa™ Spectral Calibration Panel

Version/Model Number

SC1100

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

K102314

Product Code

-

Product Code Name

-

Public Device Record Key

40da8437-b28f-4290-a6f4-0cfba09a55ea

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-