STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM

Test, Natriuretic Peptide

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Acute Care Nt-probnp Testpak, Model Cpbnpm.

Pre-market Notification Details

• Device ID: K071834
• 510k Number: K071834
• Device Name: STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
• Classification: Test, Natriuretic Peptide
• Applicant: DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101
• Contact: George M Plummer
• Correspondent: George M Plummer; DADE BEHRING, INC. 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: 2007-07-03
• Decision Date: 2007-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768019715	K071834	000