510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111369Substantially Equivalent

The Helena V8 Immunodisplacement Kit

Helena Laboratories UK Ltd, Beaumont TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K111369 is the FDA 510(k) clearance record for THE HELENA V8 IMMUNODISPLACEMENT KIT, a class II device, cleared for Helena Laboratories Uk, Ltd. on under FDA product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)). FDA records list one 510(k) clearance for Helena Laboratories Uk, Ltd. As of , FDA records show one recall naming K111369.

Clearance record

Decision date
Received
(407 days to decision)
Product code
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Helena Laboratories Uk, Ltd. P.O. Box 752, 1530 Lindebergh, Beaumont TX
510(k) summary
Statement
Third party review
No

Clearances, product code CFF

Trailing 12 months

FDA records hold no clearances under product code CFF in the trailing twelve months.

FDA records show no clearances under product code CFF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CFF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260