ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS— 510(k) K983241

Name: FDA 510(k) clearance K983241
Creator: U.S. Food and Drug Administration
Published: 1998-09-29

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K983241 for ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS, Substantially Equivalent on 1998-09-29. Applicant: Kamiya Biomedical Co.. Device class: 1.

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1998-09-15
Decision date: 1998-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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