K-number	K001547
Device name	ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
Applicant	Ab Biodisk
Product code	JWY
Device class	Class II
Decision date	Aug 7, 2000
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

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