Cleared Traditional

AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

K974620 · Trace America, Inc. · Chemistry
Jan 1998
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K974620 is an FDA 510(k) clearance for the AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST), a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on January 2, 1998, 22 days after receiving the submission on December 11, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K974620 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1997
Decision Date January 02, 1998
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIF — Enzymatic Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065

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