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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
510(k) Number K941990
Device Name BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Applicant Contact JOHN NELSON
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Correspondent Contact JOHN NELSON
Regulation Number862.3910
Classification Product Code
LFI  
Subsequent Product Code
LAA  
Date Received04/25/1994
Decision Date 03/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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