K-number	K924257
Device name	TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
Applicant	Serono-Baker Diagnostics, Inc.
Product code	CDZ
Device class	Class I
Decision date	Nov 30, 1992
Decision	Substantially Equivalent
Regulation	862.1680

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TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY

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