Catalog Number

4572459190

Brand Name

Elecsys Vitamin B12 CalSet II

Version/Model Number

4572459190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2018

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

Yes

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

K060755

Product Code

JIT

Product Code Name

CALIBRATOR, SECONDARY

Public Device Record Key

3d13b91a-c275-4e33-9271-8d9eb7f4ec0e

Public Version Date

November 11, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-