Catalog Number

07649142001

Brand Name

cobas c 513 clinical chemistry analyzer

Version/Model Number

07649142001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2018

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

K160571

Product Code

JJE

Product Code Name

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Public Device Record Key

0cc641de-3d50-4a19-aa0e-7a52aa181b5d

Public Version Date

October 09, 2020

Public Version Number

4

DI Record Publish Date

January 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-