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FDA 510(k) Application Details - K972146
Device Classification Name
Campylobacter Pylori
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510(K) Number
K972146
Device Name
Campylobacter Pylori
Applicant
CONSOLIDATED TECHNOLOGIES, INC.
2170 WOODWARD STREET, STE. 100
AUSTIN, TX 78744-1832 US
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Contact
VIPIN D SHAH
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Regulation Number
866.3110
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Classification Product Code
LYR
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Date Received
06/09/1997
Decision Date
07/08/1997
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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