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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
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