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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic, Protein Fractionation
510(k) Number K811725
Device Name TBG DIAGNOSTIC KIT
Applicant
Immuno Assay Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuno Assay Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1630
Classification Product Code
CEF  
Date Received06/18/1981
Decision Date 07/10/1981
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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