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FDA 510(k) Application Details - K061392
Device Classification Name
Device, Automated Cell-Locating
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510(K) Number
K061392
Device Name
Device, Automated Cell-Locating
Applicant
IKONISYS INC
5 SCIENCE PARK
NEW HAVEN, CT 06511 US
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Contact
S. MICHAEL SHARP
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Regulation Number
864.5260
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Classification Product Code
JOY
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More FDA Info for this Product Code
Date Received
05/19/2006
Decision Date
08/01/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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