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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K852033
Device Name SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
Applicant
Meloy Laboratories, Inc.
6715 Electronic Dr.
Springfield,  VA  22151
Applicant Contact ROBERT H FENNELL
Correspondent
Meloy Laboratories, Inc.
6715 Electronic Dr.
Springfield,  VA  22151
Correspondent Contact ROBERT H FENNELL
Regulation Number866.5100
Classification Product Code
DHN  
Date Received05/09/1985
Decision Date 06/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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