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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K844330
Device Name ALBUMIN REAGENT FOR 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 Number862.1035
Classification Product Code
CIX  
Date Received11/07/1984
Decision Date 01/03/1985
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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