K-number	K912241
Device name	STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
Applicant	Baxter Healthcare Corp
Product code	JLW
Device class	Class II
Decision date	Jun 20, 1991
Decision	Substantially Equivalent
Regulation	862.1690

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STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY

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