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510(k) K111369

THE HELENA V8 IMMUNODISPLACEMENT KIT by Helena Laboratories Uk, Ltd. — Product Code CFF

K111369 is an FDA 510(k) premarket notification submitted by Helena Laboratories Uk, Ltd. for the device "THE HELENA V8 IMMUNODISPLACEMENT KIT". The FDA issued a decision of Substantially Equivalent on June 26, 2012. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2012
Date Received
May 16, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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FDA data resources