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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Electrophoresis, For Clinical Use
510(k) Number K844710
Device Name EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD
Applicant
Logos Scientific, Inc.
700 Sunset Rd.
Henderson,  NV  89015
Applicant Contact DOUGLAS R WARD
Correspondent
Logos Scientific, Inc.
700 Sunset Rd.
Henderson,  NV  89015
Correspondent Contact DOUGLAS R WARD
Regulation Number862.2485
Classification Product Code
JJN  
Date Received12/03/1984
Decision Date 01/07/1985
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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