Name: Predicase
Price: 199 USD

K-number	K153730
Device name	ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
Applicant	Abbott Laboratories
Product code	LIP
Device class	Class II
Decision date	Jun 15, 2016
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

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