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FDA 510(k)

THE HELENA V8 IMMUNODISPLACEMENT KIT

K-Number: K111369 · 2012-06-26

ApplicantHelena Laboratories Uk, Ltd.
Decision Date2012-06-26
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THE HELENA V8 IMMUNODISPLACEMENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories Uk, Ltd.. It received FDA 510(k) clearance on 2012-06-26 under 510(k) number K111369. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE HELENA V8 IMMUNODISPLACEMENT KIT?

THE HELENA V8 IMMUNODISPLACEMENT KIT is a medical device that received FDA 510(k) clearance on 2012-06-26. The listed applicant is Helena Laboratories Uk, Ltd.. The 510(k) number is K111369.

When did THE HELENA V8 IMMUNODISPLACEMENT KIT receive FDA 510(k) clearance?

THE HELENA V8 IMMUNODISPLACEMENT KIT received FDA 510(k) clearance on 2012-06-26, under 510(k) number K111369.

Who is the listed applicant for THE HELENA V8 IMMUNODISPLACEMENT KIT?

The FDA 510(k) record lists Helena Laboratories Uk, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE HELENA V8 IMMUNODISPLACEMENT KIT?

The FDA product code for THE HELENA V8 IMMUNODISPLACEMENT KIT is CFF.

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Related Devices (Code: CFF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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