DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270

Enzymatic Method, Creatinine

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 Enzymatic Creatinine Flex Reagent Cartridge, And Enzymatic Creatinine Calibrator, Models K1270, Kc270.

Pre-market Notification Details

• Device ID: K090330
• 510k Number: K090330
• Device Name: DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
• Classification: Enzymatic Method, Creatinine
• Applicant: Siemens Healthcare Diagnostics Inc. PO BOX 6101 MS 514 Newark, DE 19714 -6101
• Contact: Rose T Marinelli
• Correspondent: Rose T Marinelli; Siemens Healthcare Diagnostics Inc. PO BOX 6101 MS 514 Newark, DE 19714 -6101
• Product Code: JFY
• CFR Regulation Number: 862.1225 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-10
• Decision Date: 2009-05-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768036262	K090330	000
00842768025419	K090330	000