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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