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510(k) K061392

IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM by Ikonisys, Inc. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2006
Date Received
May 19, 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.

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  • K052577 — IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM (January 24, 2006)

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