Name: Predicase
Price: 199 USD

K-number	K012431
Device name	COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
Applicant	Bionostics, Inc.
Product code	JJY
Device class	Class I
Decision date	Aug 28, 2001
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3

Everything you need for a 510(k) submission. Nothing you don't.