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FDA 510(k) Application Details - K102778
Device Classification Name
Device, Automated Cell-Locating
More FDA Info for this Device
510(K) Number
K102778
Device Name
Device, Automated Cell-Locating
Applicant
CELLAVISION AB
435 RICE CREEK TERRACE NE
FRIDLEY, MN 55432 US
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Contact
CONSTANCE G BUNDY
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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
09/24/2010
Decision Date
09/16/2011
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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