FDA 510(k) Application Details - DEN220028

Device Classification Name

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510(K) Number DEN220028
Device Name Cue COVID-19 Molecular Test
Applicant Cue Health Inc.
4980 Carroll Canyon Road Suite 100
San Diego, CA 92121 US
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Contact Roderick Castillo
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Regulation Number

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Classification Product Code QWB
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Date Received 05/02/2022
Decision Date 06/06/2023
Decision DENG -
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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