DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D

Enzyme Immunoassay, Lidocaine

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Lidocaine (lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator Ii, Models Df113. Dc49d.

Pre-market Notification Details

• Device ID: K033809
• 510k Number: K033809
• Device Name: DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
• Classification: Enzyme Immunoassay, Lidocaine
• 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: KLR
• CFR Regulation Number: 862.3555 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-08
• Decision Date: 2004-02-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414220680	K033809	000
00842768005305	K033809	000
00842768005176	K033809	000