K-number	K821975
Device name	ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
Applicant	Ortho Diagnostic Systems, Inc.
Product code	DIF
Device class	Class I
Decision date	Aug 27, 1982
Decision	Substantially Equivalent
Regulation	862.3280

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ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX

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