Catalog Number

-

Brand Name

Neutral Density Densitometer Control for SPIFE 4000

Version/Model Number

1033000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K972274

Product Code

CEF

Product Code Name

ELECTROPHORETIC, PROTEIN FRACTIONATION

Public Device Record Key

ffe76e28-f5a2-4a35-8116-19eed9381aef

Public Version Date

October 10, 2022

Public Version Number

6

DI Record Publish Date

March 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-