FDA 510(k) Application Details - K960909

Device Classification Name Cells, Animal And Human, Cultured

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510(K) Number K960909
Device Name Cells, Animal And Human, Cultured
Applicant NEOGENEX
12811 EIGHTH AVE. WEST, #A-102
EVERETT, WA 98204 US
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Contact E, WILLIAM RADANY, PH.D.
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Regulation Number 864.2280

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Classification Product Code KIR
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Date Received 03/05/1996
Decision Date 05/30/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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