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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 K910499
Device Name IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
Applicant
Vitek Systems, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact WINTERS HEARD
Correspondent
Vitek Systems, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact WINTERS HEARD
Regulation Number866.3305
Classification Product Code
LGC  
Date Received02/05/1991
Decision Date 05/01/1991
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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