K-number	K920583
Device name	ABBOTT QUICKSTART AMYLASE, #5AXX
Applicant	Em Diagnostic Systems, Inc.
Product code	JFJ
Device class	Class II
Decision date	Mar 2, 1992
Decision	Substantially Equivalent
Regulation	862.1070

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View the full FDA submission: accessdata.fda.gov

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ABBOTT QUICKSTART AMYLASE, #5AXX

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