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FDA 510(k) Application Details - K110722
Device Classification Name
Antigens, Cf (Including Cf Control), Adenovirus 1-33
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510(K) Number
K110722
Device Name
Antigens, Cf (Including Cf Control), Adenovirus 1-33
Applicant
RAPID PATHOGEN SCREENING, INC.
7227 DELAINEY COURT
SARASOTA, FL 34240 US
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Contact
Douglas Bueschel
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Regulation Number
866.3020
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Classification Product Code
GOD
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More FDA Info for this Product Code
Date Received
03/15/2011
Decision Date
05/17/2011
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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