DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

Enzyme Immunoassay, Digitoxin

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge.

Pre-market Notification Details

• Device ID: K062024
• 510k Number: K062024
• Device Name: DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
• Classification: Enzyme Immunoassay, Digitoxin
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Contact: Lorraine H Piestrak
• Correspondent: Lorraine H Piestrak; DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Product Code: LFM
• Subsequent Product Code: DIP
• Subsequent Product Code: KLS
• Subsequent Product Code: KXT
• Subsequent Product Code: LAN
• Subsequent Product Code: LCD
• CFR Regulation Number: 862.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-18
• Decision Date: 2006-07-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768033315	K062024	000
00842768015458	K062024	000
00842768015410	K062024	000
00842768015342	K062024	000
00842768015212	K062024	000