Cleared Traditional

PATHFAST CK-MB-II, PATHFAST MYO-II

K081360 · Mitsubishi Kagaku Iatron · Chemistry
Aug 2009
Decision
459d
Days
Class 2
Risk

About This 510(k) Submission

K081360 is an FDA 510(k) clearance for the PATHFAST CK-MB-II, PATHFAST MYO-II, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on August 17, 2009, 459 days after receiving the submission on May 15, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K081360 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2008
Decision Date August 17, 2009
Days to Decision 459 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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