CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80— 510(k) K002354

Name: FDA 510(k) clearance K002354
Creator: U.S. Food and Drug Administration
Published: 2000-09-26

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K002354 for CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80, Substantially Equivalent on 2000-09-26. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2000-08-02
Decision date: 2000-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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