K-ASSAY IGA— 510(k) K993213

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K993213 for K-ASSAY IGA, Substantially Equivalent on 1999-11-23. Applicant: Kamiya Biomedical Co.. Device class: 2.

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code CFF
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1999-09-24
Decision date: 1999-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K993213

K-number listed on FDA's recall record

Z-0271-2023 — K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013Class II·Ongoing·Kamiya Biomedical Company, LLC·20220928

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993213.

Data sourced from openFDA. This site is unofficial and independent of the FDA.