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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 K873670
Device Name SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
Applicant
Molecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego,  CA  92121
Applicant Contact PETER WESTKAEMPER
Correspondent
Molecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego,  CA  92121
Correspondent Contact PETER WESTKAEMPER
Regulation Number866.3110
Classification Product Code
LQO  
Date Received09/11/1987
Decision Date 06/08/1988
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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