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FDA 510(k) Application Details - K024350
Device Classification Name
Campylobacter Pylori
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510(K) Number
K024350
Device Name
Campylobacter Pylori
Applicant
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO, CA 92121 US
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Contact
EDWARD TUNG
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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
12/30/2002
Decision Date
04/02/2003
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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