The Helena V8 Immunodisplacement Kit

FDA 510(k) K111369 · Helena Laboratories Uk, Ltd.

Substantially Equivalent

510(k) numberK111369

Submission

Device name
The Helena V8 Immunodisplacement Kit
Applicant
Helena Laboratories Uk, Ltd.
Beaumont, TX, US
Received
May 16, 2011
Decision date
June 26, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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K082085Capillarys Immunotyping, Model 2100CFF · Traditional Sebia04/17/2009SE
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Questions and answers

When was The Helena V8 Immunodisplacement Kit cleared by the FDA?

The Helena V8 Immunodisplacement Kit (K111369) received a 510(k) decision of Substantially Equivalent on June 26, 2012, 407 days after the submission was received.

What is the product code of K111369?

The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.