K-number	K922073
Device name	STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
Applicant	Baxter Diagnostics, Inc.
Product code	DHA
Device class	Class II
Decision date	Oct 19, 1992
Decision	Substantially Equivalent
Regulation	862.1155

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STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY

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