Catalog Number

10659

Brand Name

CRP Calibrator Kit

Version/Model Number

10659

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

K130080

Product Code

JIT

Product Code Name

Calibrator, Secondary

Public Device Record Key

089563df-3b64-47a9-8f2d-66d9a42cf4fa

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-