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FDA 510(k) Application Details - K222996
Device Classification Name
More FDA Info for this Device
510(K) Number
K222996
Device Name
Access PCT
Applicant
Beckman Coulter, Inc
1000 Lake Hazeltine Drive
Chaska, MN 55318 US
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Contact
Neha Desai
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Regulation Number
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Classification Product Code
PTF
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More FDA Info for this Product Code
Date Received
09/28/2022
Decision Date
04/26/2023
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
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