DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Etoh Flex Reagent Cartridge, Model K5022.

Pre-market Notification Details

• Device ID: K070853
• 510k Number: K070853
• Device Name: DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
• Classification: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
• Applicant: DADE BEHRING, INC. P.O. Box 6101, M/S 514 Newark, DE 19714 -6101
• Contact: Victor M Carrio
• Correspondent: Victor M Carrio; DADE BEHRING, INC. P.O. Box 6101, M/S 514 Newark, DE 19714 -6101
• Product Code: DIC
• CFR Regulation Number: 862.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-28
• Decision Date: 2007-06-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768019913	K070853	000