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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K873565
Device Name SNAP(R) ROTAVIRUS DIAGNOSTIC KIT
Applicant
Molecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego,  CA  92121
Applicant Contact PETER J WESTKAEMPER
Correspondent
Molecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego,  CA  92121
Correspondent Contact PETER J WESTKAEMPER
Regulation Number866.2900
Classification Product Code
LIO  
Date Received09/02/1987
Decision Date 05/13/1988
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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