Beckman Coulter, Inc.

Beckman Coulter, Inc.

Address:7381 EMPIRE DR.,FLORENCE,KY,41042,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (8) Cytocentrifuge (IFB) (1) System, Test, Automated Blood Grouping And Antibody (KSZ) (1)

Premarket Exempt

No Yes

Clear

Cytofuge - 10873037000070 Catalog Number :

Device Description : Cytofuge® 2 Cytocentrifuge System

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : IFB

Prescription Use : Yes

Device Count : 1

PK7300 - 14987666535721 Catalog Number : N3209000

Device Description : PK7300

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : KSZ

Prescription Use : Yes

Device Count : 1

DxC AU - 14987666542491 Catalog Number :

Device Description : DxC 700 AU Chemistry Analyzer

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

DxC AU - 14987666542507 Catalog Number :

Device Description : DxC 700 AU Chemistry Analyzer, Direct Track Sampling

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

DxC AU - 14987666542514 Catalog Number :

Device Description : DxC 700 AU, Direct Track Sampling (with ISE)

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

DxC AU - 14987666542545 Catalog Number :

Device Description : DxC 700 AU Chemistry Analyzer (with ISE)

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

AU - 14987666542965 Catalog Number :

Device Description : AU480 Chemistry Analyzer

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

AU - 14987666542972 Catalog Number :

Device Description : AU480 Chemistry Analyzer (with ISE)

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

AU - 14987666542989 Catalog Number :

Device Description : AU680 Chemistry Analyzer

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

AU - 14987666542996 Catalog Number :

Device Description : AU680 Chemistry Analyzer for Direct Track Sampling (with ISE)

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

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