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FDA 510(k) Application Details - K964014
Device Classification Name
Campylobacter Pylori
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510(K) Number
K964014
Device Name
Campylobacter Pylori
Applicant
KENLOR INDUSTRIES, INC.
1560 EAST EDINGER AVE.,
SUITE A-1
SANTA ANA, CA 92705 US
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KAMALES SOM
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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
10/07/1996
Decision Date
03/03/1997
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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