DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

Cyclosporine

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Cyclosporine (csa) Flex Reagent Cartridge.

Pre-market Notification Details

• Device ID: K062236
• 510k Number: K062236
• Device Name: DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
• Classification: Cyclosporine
• Applicant: DADE BEHRING, INC. P.O. BOX BOX 6101, M/S 514 Newark, DE 19714 -6101
• Contact: Lorraine H Piestrak
• Correspondent: Lorraine H Piestrak; DADE BEHRING, INC. P.O. BOX BOX 6101, M/S 514 Newark, DE 19714 -6101
• Product Code: MKW
• CFR Regulation Number: 862.1235 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-02
• Decision Date: 2006-08-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768015144	K062236	000