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FDA 510(k) Application Details - K161139
Device Classification Name
Campylobacter Pylori
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510(K) Number
K161139
Device Name
Campylobacter Pylori
Applicant
DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER, MN 55082-0285 US
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Contact
JOHN WALTER
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Regulation Number
866.3110
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Classification Product Code
LYR
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More FDA Info for this Product Code
Date Received
04/22/2016
Decision Date
07/22/2016
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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