BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30— 510(k) K981609

Name: FDA 510(k) clearance K981609
Creator: U.S. Food and Drug Administration
Published: 1998-06-03

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K981609 for BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30, Substantially Equivalent on 1998-06-03. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1998-05-05
Decision date: 1998-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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