ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000— 510(k) K080909

Substantially Equivalent

Ikonisys, Inc.

FDA 510(k) clearance K080909 for ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000, Substantially Equivalent on 2008-10-17. Applicant: Ikonisys, Inc..

Clearance details

Applicant: Ikonisys, Inc.
Product code: Code NTH
Advisory panel: Immunology
Date received: 2008-04-01
Decision date: 2008-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Haven, CT, US

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