Catalog Number

CPK1110

Brand Name

ClearChem Diagnostics Inc. Creatine Kinase (CK)

Version/Model Number

CPK1110

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CGS

Product Code Name

NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

Public Device Record Key

cbc2a7e9-2802-4757-93ec-38f70eb09a5a

Public Version Date

May 31, 2018

Public Version Number

1

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-