Catalog Number

FPRR001

Brand Name

ichroma Reader

Version/Model Number

FPRR001

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

K132167

Product Code

OOX

Product Code Name

Automated Occult Blood Analyzer

Public Device Record Key

74b93905-e7cd-4f14-a240-c093d3915334

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-