510(k) K071834

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM by Dade Behring, Inc. — Product Code NBC

K071834 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM". The FDA issued a decision of Substantially Equivalent on August 17, 2007. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2007
Date Received
July 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type