DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

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

Siemens Healthcare Diagnostics Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista Loci Ca 19-9 Flex Reagent Cartridge, And Dimension Loci7 Calibrator With Model(s) K6457, And Kc604.

Pre-market Notification Details

• Device ID: K100375
• 510k Number: K100375
• Device Name: DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
• Classification: System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
• Applicant: Siemens Healthcare Diagnostics Inc. PO BOX 6101 M/S 514 Newark, DE 19714 -6101
• Contact: Pamela Jurga
• Correspondent: Pamela Jurga; Siemens Healthcare Diagnostics Inc. PO BOX 6101 M/S 514 Newark, DE 19714 -6101
• Product Code: NIG
• CFR Regulation Number: 866.6010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-12
• Decision Date: 2011-04-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768029332	K100375	000
00842768028533	K100375	000