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FDA 510(k) Application Details - K955085
Device Classification Name
Campylobacter Pylori
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510(K) Number
K955085
Device Name
Campylobacter Pylori
Applicant
SCHIFF & CO.
1129 BLOOMFIELD AVE.
WEST CALDWELL, NJ 07006 US
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Contact
Gary Lehnus
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Regulation Number
866.3110
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Classification Product Code
LYR
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Date Received
10/26/1995
Decision Date
02/09/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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