K-number	K972307
Device name	ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
Applicant	Boston Biomedica, Inc.
Product code	JJY
Device class	Class I
Decision date	Aug 7, 1997
Decision	Substantially Equivalent
Regulation	862.1660

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ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL

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