DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632

System, Test, Human Chorionic Gonadotropin

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista (tm) Bhcg Flex(r) Reagent Cartridge, And Bhcg Calibrator, Model# K6430,kc632.

Pre-market Notification Details

• Device ID: K063754
• 510k Number: K063754
• Device Name: DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
• Classification: System, Test, Human Chorionic Gonadotropin
• Applicant: DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Contact: Pamela A Jurga
• Correspondent: Pamela A Jurga; DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101
• Product Code: DHA
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-12-19
• Decision Date: 2007-02-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768016516	K063754	000
00842768015540	K063754	000