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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K910160
Device Name ELECTROPHORESIS CONTROL
Applicant
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Applicant Contact MICHAEL J SULLIVAN
Correspondent
Seradyn, Inc.
P.O. Box 1210
Indianapolis,  IN  46206
Correspondent Contact MICHAEL J SULLIVAN
Regulation Number862.1150
Classification Product Code
JIT  
Date Received01/15/1991
Decision Date 02/27/1991
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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