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FDA 510(k) Application Details - K171641
Device Classification Name
More FDA Info for this Device
510(K) Number
K171641
Device Name
Accula Flu A/Flu B Test
Applicant
Mesa Biotech, Inc.
6190 Cornerstone Court, Suite 220
SAN DIEGO, CA 92121 US
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Contact
Barbara E. Stevens
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Regulation Number
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Classification Product Code
OZE
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More FDA Info for this Product Code
Date Received
06/02/2017
Decision Date
02/06/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Dual Track
Reviewed By Third Party
N
Expedited Review
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