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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion-Specific, Chloride
510(k) Number K844021
Device Name ISE REAGENTS 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 Number862.1170
Classification Product Code
CGZ  
Date Received10/15/1984
Decision Date 12/10/1984
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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