K-number	K031647
Device name	BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
Applicant	Getinge USA, Inc.
Product code	JOJ
Device class	Class II
Decision date	Jul 29, 2003
Decision	Substantially Equivalent
Regulation	880.2800

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View the full FDA submission: accessdata.fda.gov

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BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

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