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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 K944728
Device Name BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL
Applicant
Bioresource Technology, Inc.
4970 Southwest 52 St.
Suite 325
Fort Lauderdale,  FL  33311
Applicant Contact ALAN POSNER
Correspondent
Bioresource Technology, Inc.
4970 Southwest 52 St.
Suite 325
Fort Lauderdale,  FL  33311
Correspondent Contact ALAN POSNER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/26/1994
Decision Date 03/23/1995
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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