MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT— 510(k) K862834

Name: FDA 510(k) clearance K862834
Creator: U.S. Food and Drug Administration
Published: 1986-08-19

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K862834 for MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT, Substantially Equivalent on 1986-08-19. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1986-07-25
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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