Cleared Traditional

IKONISCOPE ONCOFISH BLADDER TEST SYSTEM

K062755 · Ikonisys, Inc. · Hematology
Jan 2007
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K062755 is an FDA 510(k) clearance for the IKONISCOPE ONCOFISH BLADDER TEST SYSTEM, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Ikonisys, Inc. (New Haven, US). The FDA issued a Cleared decision on January 4, 2007, 112 days after receiving the submission on September 14, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K062755 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2006
Decision Date January 04, 2007
Days to Decision 112 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOY — Device, Automated Cell-locating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5260

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