K-number	K820255
Device name	BI-LEVEL ASSAYED URINE METAL CONTROL
Applicant	Ortho Diagnostic Systems, Inc.
Product code	JJY
Device class	Class I
Decision date	Feb 18, 1982
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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BI-LEVEL ASSAYED URINE METAL CONTROL

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