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FDA 510(k) Application Details - K220801
Device Classification Name
More FDA Info for this Device
510(K) Number
K220801
Device Name
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Applicant
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074 US
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Contact
Jessica Stahle
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OZE
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More FDA Info for this Product Code
Date Received
03/18/2022
Decision Date
06/24/2022
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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