DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132

Flame Photometry, Lithium

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Lithium (li) Flex Reagent Cartridge, Model Df 132.

Pre-market Notification Details

• Device ID: K011033
• 510k Number: K011033
• Device Name: DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
• Classification: Flame Photometry, Lithium
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101
• Contact: Richard M Vaught
• Correspondent: Richard M Vaught; DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101
• Product Code: JIH
• CFR Regulation Number: 862.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-05
• Decision Date: 2001-06-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768005367	K011033	000