K-number	K922043
Device name	ROCHE CALIBRATOR SERUM
Applicant	Roche Diagnostic Systems, Inc.
Product code	JIX
Device class	Class II
Decision date	Jun 16, 1992
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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ROCHE CALIBRATOR SERUM

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