Name: Predicase
Price: 199 USD

K-number	K062516
Device name	ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
Applicant	Beckman Coulter, Inc.
Product code	JNL
Device class	Class II
Decision date	Oct 5, 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 THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)

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