MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12— 510(k) K042362

Name: FDA 510(k) clearance K042362
Creator: U.S. Food and Drug Administration
Published: 2004-12-27

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K042362 for MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12, Substantially Equivalent on 2004-12-27. 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: 2004-08-31
Decision date: 2004-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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