CHLORIDE ASSAY KIT— 510(k) K852058

Name: FDA 510(k) clearance K852058
Creator: U.S. Food and Drug Administration
Published: 1985-07-12

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K852058 for CHLORIDE ASSAY KIT, Substantially Equivalent on 1985-07-12. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CHJ
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 1985-05-09
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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