AU - AU5800 Chemistry Analyzer, Automation-ready - Beckman Coulter, Inc.

Duns Number:008254708

Device Description: AU5800 Chemistry Analyzer, Automation-ready

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More Product Details

Catalog Number

-

Brand Name

AU

Version/Model Number

B96698

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K112412

Product Code Details

Product Code

JJE

Product Code Name

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device Record Status

Public Device Record Key

4b49d4b2-bbbc-42a9-b4b8-e15146d6bf8f

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

August 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECKMAN COULTER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 319
2 A medical device with a moderate to high risk that requires special controls. 503
3 A medical device with high risk that requires premarket approval 9
U Unclassified 1