K-number	K780002
Device name	ANTITHROMBIN III ASSAY
Applicant	Ortho Diagnostics, Inc.
Product code	JBQ
Device class	Class II
Decision date	Jan 31, 1978
Decision	Substantially Equivalent
Regulation	864.7060

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View the full FDA submission: accessdata.fda.gov

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ANTITHROMBIN III ASSAY

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