THE HELENA V8 IMMUNODISPLACEMENT KIT— 510(k) K111369

Name: FDA 510(k) clearance K111369
Creator: U.S. Food and Drug Administration
Published: 2012-06-26

Substantially Equivalent

Helena Laboratories Uk, Ltd.

FDA 510(k) clearance K111369 for THE HELENA V8 IMMUNODISPLACEMENT KIT, Substantially Equivalent on 2012-06-26. Applicant: Helena Laboratories Uk, Ltd.. Device class: 2.

Clearance details

Applicant: Helena Laboratories Uk, Ltd.
Product code: Code CFF
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2011-05-16
Decision date: 2012-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K111369

K-number listed on FDA's recall record

Z-1244-2022 — V8 Immunodisplacement Kit REF 1803Class II·Ongoing·Helena Laboratories, Corp.·20220406

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111369.

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