ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

System, Test, Carcinoembryonic Antigen

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Cea Reagents For Use On The Access Immunoassay Systems.

Pre-market Notification Details

• Device ID: K031270
• 510k Number: K031270
• Device Name: ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
• Classification: System, Test, Carcinoembryonic Antigen
• Applicant: BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084
• Contact: Lynn Weist
• Correspondent: Lynn Weist; BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084
• Product Code: DHX
• CFR Regulation Number: 866.6010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-21
• Decision Date: 2003-05-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590624842	K031270	000
15099590624835	K031270	000
15099590624828	K031270	000
15099590624811	K031270	000