K-number	K110394
Device name	ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
Applicant	Vital Diagnostics (Manufacturing) Ptyltd
Product code	JIX
Device class	Class II
Decision date	Jun 9, 2011
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

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