FDA 510(k) Application Details - K830939

Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation

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510(K) Number K830939
Device Name Discs, Strips And Reagents, Microorganism Differentiation
Applicant OXOID U.S.A., INC.

, US
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Regulation Number 866.2660

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Classification Product Code JTO
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Date Received 03/24/1983
Decision Date 04/13/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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