GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688

System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Gi Monitor And Gi Monitor Calibrators On The Access Immunoassay Systems, Model 387687, 387688.

Pre-market Notification Details

• Device ID: K033038
• 510k Number: K033038
• Device Name: GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
• Classification: System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
• Applicant: BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084
• Contact: Brent Taber
• Correspondent: Brent Taber; BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084
• Product Code: NIG
• CFR Regulation Number: 866.6010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-29
• Decision Date: 2003-12-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590231842	K033038	000
15099590231835	K033038	000