Catalog Number

20299

Brand Name

Sofia

Version/Model Number

20299

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

K162911

Product Code

KHO

Product Code Name

FLUOROMETER, FOR CLINICAL USE

Public Device Record Key

e3ff4f23-2613-490d-8967-92d0590f637b

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-