Catalog Number

315-A995-00

Brand Name

SPOTCHECK

Version/Model Number

315-A995-00

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

K101392

Product Code

JJC

Product Code Name

Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

Public Device Record Key

1e96fa21-ea45-447b-a6b7-2629261e2e91

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

-