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FDA 510(k) Application Details - K961508
Device Classification Name
Campylobacter Pylori
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510(K) Number
K961508
Device Name
Campylobacter Pylori
Applicant
MERIDIAN DIAGNOSTICS, INC.
3471 RIVER HILLS DR.
CINCINNATI, OH 45244 US
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Contact
ALLEN D NICKOL, PH.D.
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Regulation Number
866.3110
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Classification Product Code
LYR
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Date Received
04/19/1996
Decision Date
01/21/1997
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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