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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K925326
Device Name ELECTROPHORESIS CONTROL LEVEL 1
Applicant
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact ANDRIS INDRIKSONS
Correspondent
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact ANDRIS INDRIKSONS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/21/1992
Decision Date 03/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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