K-number	K850901
Device name	DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
Applicant	Data Medical Associates, Inc.
Product code	CIG
Device class	Class II
Decision date	Apr 1, 1985
Decision	Substantially Equivalent
Regulation	862.1110

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View the full FDA submission: accessdata.fda.gov

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DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE

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