DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR

Photometric Method, Iron (non-heme)

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Iron Flex Reagent Cartridge And Calibrator.

Pre-market Notification Details

• Device ID: K061793
• 510k Number: K061793
• Device Name: DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
• Classification: Photometric Method, Iron (non-heme)
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark, DE 19714 -6101
• Contact: Andrea M Tasker
• Correspondent: Andrea M Tasker; DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark, DE 19714 -6101
• Product Code: JIY
• CFR Regulation Number: 862.1410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-26
• Decision Date: 2006-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768015854	K061793	000
00842768015236	K061793	000