ENZYMATIC ACETAMINOPHEN ASSAY— 510(k) K841930

Name: FDA 510(k) clearance K841930
Creator: U.S. Food and Drug Administration
Published: 1984-06-25

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K841930 for ENZYMATIC ACETAMINOPHEN ASSAY, Substantially Equivalent on 1984-06-25. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code LKP
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1984-05-10
Decision date: 1984-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, US

Download summary PDF View on FDA.gov ↗

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