DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

Enzyme Immunoassay, Procainamide

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Procainamide (proc) Flex Reagent Cartridge Method, Model Df110.

Pre-market Notification Details

• Device ID: K032573
• 510k Number: K032573
• Device Name: DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
• Classification: Enzyme Immunoassay, Procainamide
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 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 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Product Code: LAR
• CFR Regulation Number: 862.3320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-20
• Decision Date: 2003-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414220673	K032573	000
00842768005282	K032573	000