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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, General Use, Thin Layer Chromatography
510(k) Number K904326
Device Name DE-TOX TUBES A AND DE-TOX TUBES B
Applicant
Dyna-Tek Industries
8971 Hall Dr.
Lenexa,  KS  66219
Applicant Contact PAUL SOOD
Correspondent
Dyna-Tek Industries
8971 Hall Dr.
Lenexa,  KS  66219
Correspondent Contact PAUL SOOD
Regulation Number862.2270
Classification Product Code
DPA  
Date Received09/20/1990
Decision Date 01/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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