Cleared Traditional

CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL

K972976 · More Diagnostics · Chemistry
Aug 1997
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K972976 is an FDA 510(k) clearance for the CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on August 29, 1997, 18 days after receiving the submission on August 11, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K972976 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1997
Decision Date August 29, 1997
Days to Decision 18 days
Submission Type Traditional
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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