Catalog Number

303-A980-00A

Brand Name

SPOTCHECK

Version/Model Number

303-A980-00A

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

K883020

Product Code

JJF

Product Code Name

Analyzer, Chemistry, Micro, For Clinical Use

Public Device Record Key

36b267eb-ad74-47f0-8a37-29b1ce7948a0

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-