Cleared Traditional

SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458

K061069 · Helena Laboratories · Immunology

Jul 2006

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K061069 is an FDA 510(k) clearance for the SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on July 6, 2006, 80 days after receiving the submission on April 17, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K061069 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2006
Decision Date	July 06, 2006
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF