Catalog Number

RE69991.

Brand Name

SaliCaps

Version/Model Number

RE69991.

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040923

Product Code

JLS

Product Code Name

Radioimmunoassay, Progesterone

Public Device Record Key

09556c69-da69-4a9c-ae36-322c21072ccb

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

December 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-