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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, Cytomegalovirus
510(k) Number K921011
Device Name PHARMACIA CMV IGM ELISA
Applicant
Pharmacia Diagnostics, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Applicant Contact STEVEN VINSON
Correspondent
Pharmacia Diagnostics, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
Correspondent Contact STEVEN VINSON
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received03/03/1992
Decision Date 07/27/1992
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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