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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K863265
Device Name DIRECT BILIRUBIN PROCEDURE
Applicant
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact MARJORIE B POTTS
Correspondent
Data Medical Associates, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact MARJORIE B POTTS
Regulation Number862.1110
Classification Product Code
CIG  
Date Received08/25/1986
Decision Date 10/24/1986
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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