Catalog Number

1513209

Brand Name

VITROS

Version/Model Number

1513209

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

-

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

K932729

Product Code

CEO

Product Code Name

Phosphomolybdate (colorimetric), inorganic phosphorus

Public Device Record Key

46f6eeaf-364e-4d38-995f-b3dac57366c7

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-