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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K844743
Device Name SERATEST ENA(RNP/SM) DETERMINATION
Applicant
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact MICHAEL J SULLIVAN
Correspondent
Seragen Diagnostics, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact MICHAEL J SULLIVAN
Regulation Number866.5100
Classification Product Code
LLL  
Date Received12/05/1984
Decision Date 02/04/1985
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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