Cleared Traditional

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

K001285 · Diagnostic Chemicals , Ltd. · Chemistry
Jun 2000
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K001285 is an FDA 510(k) clearance for the AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30, 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 June 2, 2000, 42 days after receiving the submission on April 21, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K001285 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2000
Decision Date June 02, 2000
Days to Decision 42 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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