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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Mumps Virus
510(k) Number K991274
Device Name MUMPS IGG ELISA TEST SYSTEM
Applicant
Columbia Bioscience, Inc.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Applicant Contact NORMAN JENKINS
Correspondent
Columbia Bioscience, Inc.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Correspondent Contact NORMAN JENKINS
Regulation Number866.3380
Classification Product Code
LJY  
Date Received04/13/1999
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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