FDA 510(k) Application Details - K936169

Device Classification Name Cells, Animal And Human, Cultured

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510(K) Number K936169
Device Name Cells, Animal And Human, Cultured
Applicant ADVANCED CLINICAL DIAGNOSTICS
1021 BROADWAY
TOLEDO, OH US
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Contact P.S. THOMBRE
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Regulation Number 864.2280

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Classification Product Code KIR
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Date Received 12/23/1993
Decision Date 02/03/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee PA - Pathology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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