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510(k) K062755

IKONISCOPE ONCOFISH BLADDER TEST SYSTEM by Ikonisys, Inc. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2007
Date Received
September 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
Submission Type

Other clearances by Ikonisys, Inc.

  • K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (October 17, 2008)
  • K061392 — IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM (August 1, 2006)
  • K052577 — IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM (January 24, 2006)

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