DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)

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 Iron Flex Reagent Cartridge (iron-df85).

Pre-market Notification Details

• Device ID: K060264
• 510k Number: K060264
• Device Name: DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
• Classification: Photometric Method, Iron (non-heme)
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714
• Contact: Andrea M Tasker
• Correspondent: Andrea M Tasker; DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714
• Product Code: JIY
• CFR Regulation Number: 862.1410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-02-01
• Decision Date: 2006-03-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768020414	K060264	000