K-number	K821869
Device name	ULTRAZYME PLUS AMYL
Applicant	Harleco Diagnostics
Product code	JFJ
Device class	Class II
Decision date	Jul 13, 1982
Decision	Substantially Equivalent
Regulation	862.1070

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View the full FDA submission: accessdata.fda.gov

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ULTRAZYME PLUS AMYL

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