Name: Predicase
Price: 199 USD

K-number	K061382
Device name	ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
Applicant	Beckman Coulter, Inc.
Product code	JZO
Device class	Class II
Decision date	Jul 6, 2006
Decision	Substantially Equivalent
Regulation	866.5870

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Source

View the full FDA submission: accessdata.fda.gov

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ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227

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