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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, Herpes Simplex Virus, Non-Specific
510(k) Number K963282
Device Name SERAQUEST HSV IGG
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 Number866.3305
Classification Product Code
LGC  
Date Received08/21/1996
Decision Date 01/22/1997
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
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