K-number	K042303
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
Applicant	Ortho-Clinical Diagnostics
Product code	JJX
Device class	Class I
Decision date	Sep 27, 2004
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

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