K-number	K964889
Device name	ELECSYS TESTOSTERONE ASSAY
Applicant	Boehringer Mannheim Corp.
Product code	CDZ
Device class	Class I
Decision date	Mar 18, 1997
Decision	Substantially Equivalent
Regulation	862.1680

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View the full FDA submission: accessdata.fda.gov

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ELECSYS TESTOSTERONE ASSAY

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