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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Reagents, Campylobacter Spp.
510(k) Number K863270
Device Name GENE-TRAK CAMPYLOBACTER ASSAY
Applicant
Integrated Genetics
32 New York Ave.
Framingham,  MA  01701
Applicant Contact KARENLEE VOLTZ-DOW
Correspondent
Integrated Genetics
32 New York Ave.
Framingham,  MA  01701
Correspondent Contact KARENLEE VOLTZ-DOW
Regulation Number866.3110
Classification Product Code
LQO  
Date Received08/25/1986
Decision Date 08/31/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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