Cleared Traditional

IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM

K061392 · Ikonisys, Inc. · Hematology
Aug 2006
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K061392 is an FDA 510(k) clearance for the IKONISCOPE FASTFISH AUTO/AMNIOCYTE 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 August 1, 2006, 74 days after receiving the submission on May 19, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K061392 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2006
Decision Date August 01, 2006
Days to Decision 74 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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