DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT

Immunoassay Method, Troponin Subunit

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator And Sdil Sample Diluent.

Pre-market Notification Details

• Device ID: K053577
• 510k Number: K053577
• Device Name: DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
• Classification: Immunoassay Method, Troponin Subunit
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Contact: George M Plummer
• Correspondent: George M Plummer; DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Product Code: MMI
• CFR Regulation Number: 862.1215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-22
• Decision Date: 2006-04-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768016738	K053577	000