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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 K897006
Device Name PHARMACIA MUMPS IGG ELISA
Applicant
Pharmacia Eni Diagnostics, Inc.
8310 Guilford Rd.
Suite E
Columbia,  MD  21046
Applicant Contact KAREN DARCY
Correspondent
Pharmacia Eni Diagnostics, Inc.
8310 Guilford Rd.
Suite E
Columbia,  MD  21046
Correspondent Contact KAREN DARCY
Regulation Number866.3380
Classification Product Code
LJY  
Date Received12/18/1989
Decision Date 07/26/1990
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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