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510(k) K052577

IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM by Ikonisys, Inc. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2006
Date Received
September 19, 2005
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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  • K061392 — IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM (August 1, 2006)

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