Name: Predicase
Price: 199 USD

K-number	K080634
Device name	ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
Applicant	Beckman Coulter, Inc.
Product code	DDG
Device class	Class II
Decision date	Aug 11, 2008
Decision	Substantially Equivalent
Regulation	866.5880

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Source

View the full FDA submission: accessdata.fda.gov

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ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495

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