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FDA 510(k) Application Details - K001460
Device Classification Name
Campylobacter Pylori
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510(K) Number
K001460
Device Name
Campylobacter Pylori
Applicant
BIOMERIEUX, INC.
1022 HINGHAM ST.
ROCKLAND, MA 02370 US
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Contact
JANET CONNOLLY
Other 510(k) Applications for this Contact
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
05/10/2000
Decision Date
10/04/2000
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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