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FDA 510(k) Application Details - K151935
Device Classification Name
Campylobacter Pylori
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510(K) Number
K151935
Device Name
Campylobacter Pylori
Applicant
ALERE SAN DIEGO, INCORPORATED
9975 SUMMERS RIDGE ROAD
SAN DIEGO, CA 92121 US
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Contact
JOSEPH DE LA ROSA
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Regulation Number
866.3110
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Classification Product Code
LYR
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Date Received
07/14/2015
Decision Date
08/12/2015
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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