Cleared Special

MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

K062751 · Quantimetrix Corp. · Chemistry
Oct 2006
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K062751 is an FDA 510(k) clearance for the MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on October 3, 2006, 19 days after receiving the submission on September 14, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K062751 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2006
Decision Date October 03, 2006
Days to Decision 19 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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