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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K052577
Device Name IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
Applicant
IKONISYS INC
5 SCIENCE PARK
SUITE 1000
NEW HAVEN,  CT  06511
Applicant Contact S. MICHAEL SHARP
Correspondent
IKONISYS INC
5 SCIENCE PARK
SUITE 1000
NEW HAVEN,  CT  06511
Correspondent Contact S. MICHAEL SHARP
Regulation Number864.5260
Classification Product Code
JOY  
Date Received09/19/2005
Decision Date 01/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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