Cleared Traditional

AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

K033921 · Diagnostic Chemicals , Ltd. · Chemistry
Mar 2004
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K033921 is an FDA 510(k) clearance for the AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on March 10, 2004, 83 days after receiving the submission on December 18, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K033921 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2003
Decision Date March 10, 2004
Days to Decision 83 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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