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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Thyroxine
510(k) Number K926563
Device Name AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT
Applicant
Bio-Chem Laboratory Systems, Inc.
195 Lehigh Ave.
Lakewood,  NJ  08701
Applicant Contact JON D TURPEN
Correspondent
Bio-Chem Laboratory Systems, Inc.
195 Lehigh Ave.
Lakewood,  NJ  08701
Correspondent Contact JON D TURPEN
Regulation Number862.1700
Classification Product Code
CDX  
Date Received12/31/1992
Decision Date 03/18/1993
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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