FDA 510(k) Application Details - K874320

Device Classification Name Counter, Cell, Automated (Particle Counter)

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510(K) Number K874320
Device Name Counter, Cell, Automated (Particle Counter)
Applicant INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
P.O. BOX 9113
LEXINGTON, MA US
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Contact GEORGE A LYNA
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Regulation Number 864.5200

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Classification Product Code GKL
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Date Received 10/21/1987
Decision Date 01/27/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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