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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K930006
Device Name AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT 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 Number862.1690
Classification Product Code
JLW  
Date Received01/04/1993
Decision Date 09/09/1993
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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