Cleared Traditional

K083412 - PATHFAST HSCRP
(FDA 510(k) Clearance)

K083412 · Mitsubishi Kagaku Iatron · Chemistry

Mar 2009

Decision

111d

Days

Class 2

Risk

K083412 is an FDA 510(k) clearance for the PATHFAST HSCRP. This device is classified as a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN).

Submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on March 9, 2009, 111 days after receiving the submission on November 18, 2008.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K083412 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2008
Decision Date	March 09, 2009
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement