Name: Predicase
Price: 199 USD

K-number	K111150
Device name	STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
Applicant	Steritec Products Mfg Co, Inc.
Product code	FRC
Device class	Class II
Decision date	Jul 8, 2011
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

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