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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Centrifugal, For Clinical Use
510(k) Number K851619
Device Name GEN PROFILER SYSTEM
Applicant
Electro-Cucleonics, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Applicant Contact EUGENE H LABREC
Correspondent
Electro-Cucleonics, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Correspondent Contact EUGENE H LABREC
Regulation Number862.2140
Classification Product Code
JJG  
Date Received04/18/1985
Decision Date 05/14/1985
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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