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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 K802245
Device Name 7 TRICYCLIC ANTIDE PRESSANTS
Applicant
Technicon Instruments Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Technicon Instruments Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3910
Classification Product Code
LFI  
Date Received09/16/1980
Decision Date 10/10/1980
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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