K-number	K964368
Device name	ELECSYS CEA ASSAY
Applicant	Boehringer Mannheim Corp.
Product code	JIT
Device class	Class II
Decision date	Jun 16, 1997
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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ELECSYS CEA ASSAY

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