BILIRUBIN ASSAY KIT DIRECT— 510(k) K843027

Name: FDA 510(k) clearance K843027
Creator: U.S. Food and Drug Administration
Published: 1984-09-04

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K843027 for BILIRUBIN ASSAY KIT DIRECT, Substantially Equivalent on 1984-09-04. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1984-08-01
Decision date: 1984-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, US

Download summary PDF View on FDA.gov ↗

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