Cleared Traditional

IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM

K052577 · Ikonisys, Inc. · Hematology
Jan 2006
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K052577 is an FDA 510(k) clearance for the IKONISCOPE FASTFISH AMNIO IMAGING 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 24, 2006, 127 days after receiving the submission on September 19, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number K052577 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2005
Decision Date January 24, 2006
Days to Decision 127 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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