Catalog Number

-

Brand Name

Automated Blood Coagulation Analyzer CA-600 series CA-660

Version/Model Number

CK978289

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

K031377

Product Code

GKP

Product Code Name

INSTRUMENT, COAGULATION, AUTOMATED

Public Device Record Key

e09975ba-1d4f-42c1-bce5-c41182d08605

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

August 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-