Cleared Traditional

VISULIZE FACTOR IX ANTIGEN KIT

K051054 · Affinity Biologicals, Inc. · Hematology
Jun 2005
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K051054 is an FDA 510(k) clearance for the VISULIZE FACTOR IX ANTIGEN KIT, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Affinity Biologicals, Inc. (Ancaster, Ontario, CA). The FDA issued a Cleared decision on June 29, 2005, 64 days after receiving the submission on April 26, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K051054 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2005
Decision Date June 29, 2005
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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