Cleared Traditional

PATHFAST NTPROBNP AND D-DIMER TESTS

K072189 · Mitsubishi Kagaku Iatron · Chemistry

Feb 2008

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K072189 is an FDA 510(k) clearance for the PATHFAST NTPROBNP AND D-DIMER TESTS, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on February 5, 2008, 183 days after receiving the submission on August 6, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number	K072189 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2007
Decision Date	February 05, 2008
Days to Decision	183 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement