DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A

Test, Natriuretic Peptide

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimensions Pbnp Flex Reagent Cartridge, Model Rf423a.

Pre-market Notification Details

• Device ID: K071767
• 510k Number: K071767
• Device Name: DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
• Classification: Test, Natriuretic Peptide
• Applicant: DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Contact: Pamela A Jurga
• Correspondent: Pamela A Jurga; DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101
• Product Code: NBC
• CFR Regulation Number: 862.1117 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-06-29
• Decision Date: 2007-08-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768016950	K071767	000
00842768016936	K071767	000