CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50— 510(k) K990754

Name: FDA 510(k) clearance K990754
Creator: U.S. Food and Drug Administration
Published: 1999-04-20

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K990754 for CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50, Substantially Equivalent on 1999-04-20. 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: 1999-03-08
Decision date: 1999-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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