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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 K982485
Device Name SERAQUEST CMV IGM
Applicant
Quest Intl., Inc.
1938 NE 148th Terr.
North Miami,  FL  33181
Applicant Contact ROBERT A CORT
Correspondent
Quest Intl., Inc.
1938 NE 148th Terr.
North Miami,  FL  33181
Correspondent Contact ROBERT A CORT
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received07/17/1998
Decision Date 01/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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