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FDA 510(k) Application Details - K231017
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
More FDA Info for this Device
510(K) Number
K231017
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
Hologic, Inc.
10210 Genetic Center Dr
SAN DIEGO, CA 92121 US
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Contact
Jon Kukowski
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Regulation Number
866.3980
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Classification Product Code
OCC
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More FDA Info for this Product Code
Date Received
04/10/2023
Decision Date
05/05/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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