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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Salicylate
510(k) Number K852027
Device Name GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
Applicant
Advanced Biomedical Methods, Inc.
P.O. Box 48026
Niles,  IL  60648
Applicant Contact JACK M GOLDBERG
Correspondent
Advanced Biomedical Methods, Inc.
P.O. Box 48026
Niles,  IL  60648
Correspondent Contact JACK M GOLDBERG
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received05/08/1985
Decision Date 05/29/1985
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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