Catalog Number

910-0500-00

Brand Name

SPOTCHECK

Version/Model Number

910-0500-00

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

K102643

Product Code

JJQ

Product Code Name

Colorimeter, Photometer, Spectrophotometer For Clinical Use

Public Device Record Key

80050ee3-8f87-45e8-ad9f-cb5f643768a7

Public Version Date

September 16, 2022

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

-