DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05— 510(k) K955880

Name: FDA 510(k) clearance K955880
Creator: U.S. Food and Drug Administration
Published: 1996-08-27

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K955880 for DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05, Substantially Equivalent on 1996-08-27. 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: 1995-12-28
Decision date: 1996-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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