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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 K955812
Device Name SYSCON TURMOR MARKER CONTROL
Applicant
Scantibodies Laboratory, Inc.
9251 SW 52nd Terrace
Miami,  FL  33165
Applicant Contact ROSETTA GEFFEN
Correspondent
Scantibodies Laboratory, Inc.
9251 SW 52nd Terrace
Miami,  FL  33165
Correspondent Contact ROSETTA GEFFEN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/26/1995
Decision Date 03/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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