FDA 510(k) Application Details - K850090

Device Classification Name Media And Components, Synthetic Cell And Tissue Culture

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510(K) Number K850090
Device Name Media And Components, Synthetic Cell And Tissue Culture
Applicant SIGMA CHEMICAL CO.
P.O. BOX 14508
ST. LOUIS, MO US
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Contact JAN BAKER
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Regulation Number 864.2220

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Classification Product Code KIT
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Date Received 01/11/1985
Decision Date 02/27/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee PA - Pathology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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