FDA 510(k) Application Details - K233324

Device Classification Name

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510(K) Number K233324
Device Name Molecular Transport Media - MTM
Applicant ALB Luz
Rua Um, 437
Valinhos 13273-200 BR
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Contact Ana Luiza Bueno Luz
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Regulation Number

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Classification Product Code QBD
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Date Received 09/29/2023
Decision Date 06/17/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233324


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