Catalog Number

-

Brand Name

Sunmark Pregnancy Test One Step

Version/Model Number

FPPL

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042280,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

f0391ac4-780b-4028-b074-d70cdb96a9e5

Public Version Date

June 11, 2020

Public Version Number

4

DI Record Publish Date

June 30, 2016

Package DI Number

10010939162332

Quantity per Package

24

Contains DI Package

00010939162335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case