DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

Enzyme Immunoassay, N-acetylprocainamide

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension N-acetylprocainamide (napa) Flex Reagent Cartridge Method, Model Df111.

Pre-market Notification Details

• Device ID: K032564
• 510k Number: K032564
• Device Name: DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
• Classification: Enzyme Immunoassay, N-acetylprocainamide
• 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: LAN
• 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
00630414220659	K032564	000
00842768005299	K032564	000