Catalog Number

SK328-40

Brand Name

Alkaline Phosphatase

Version/Model Number

SK328-40

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

K003093

Product Code

CJE

Product Code Name

NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Public Device Record Key

8762c82d-d573-45c4-b0a1-b23bbe2f4d6c

Public Version Date

December 31, 2018

Public Version Number

1

DI Record Publish Date

November 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-