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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Leukocyte Typing
510(k) Number K874544
Device Name SNAP(R) CAMPYLOBACTER CULTURE IDENT 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 Number864.7675
Classification Product Code
LGO  
Date Received11/03/1987
Decision Date 08/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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