CREATININE ASSAY KIT-KINETIC OR ENDPOINT— 510(k) K842159

Name: FDA 510(k) clearance K842159
Creator: U.S. Food and Drug Administration
Published: 1984-08-16

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K842159 for CREATININE ASSAY KIT-KINETIC OR ENDPOINT, Substantially Equivalent on 1984-08-16. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1984-05-30
Decision date: 1984-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, US

Download summary PDF View on FDA.gov ↗

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