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FDA 510(k) Application Details - K973508
Device Classification Name
Campylobacter Pylori
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510(K) Number
K973508
Device Name
Campylobacter Pylori
Applicant
MICRO DETECT, INC.
23016 DEL LAGO DR., SUITE B
LAGUNA HILLS, CA 92653 US
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Contact
MEHDI ALEM PH.D.
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Regulation Number
866.3110
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Classification Product Code
LYR
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Date Received
09/16/1997
Decision Date
03/10/1998
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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