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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K930689
Device Name AUTOBEAD THYROID UPTAKE
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 Number862.2560
Classification Product Code
KHO  
Date Received02/10/1993
Decision Date 11/10/1993
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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