Cleared Traditional

CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80

K002354 · Diagnostic Chemicals , Ltd. · Toxicology
Sep 2000
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K002354 is an FDA 510(k) clearance for the CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on September 26, 2000, 55 days after receiving the submission on August 2, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K002354 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2000
Decision Date September 26, 2000
Days to Decision 55 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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