Catalog Number

08834059190

Brand Name

small dense LDL Seiken

Version/Model Number

08834059190

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161679

Product Code

PYP

Product Code Name

Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

Public Device Record Key

b5f389ce-d1cf-4329-9746-143c175416ae

Public Version Date

October 21, 2020

Public Version Number

1

DI Record Publish Date

October 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-