Cleared Traditional

CARDIASURE CARDIAC MARKERS CONTROL

K993723 · Quantimetrix Corp. · Chemistry
Nov 1999
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K993723 is an FDA 510(k) clearance for the CARDIASURE CARDIAC MARKERS CONTROL, 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 November 23, 1999, 20 days after receiving the submission on November 3, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K993723 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1999
Decision Date November 23, 1999
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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