Name: Predicase
Price: 199 USD

K-number	K001444
Device name	STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
Applicant	Steritec Products, Inc.
Product code	JOJ
Device class	Class II
Decision date	May 15, 2000
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103

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