Name: Predicase
Price: 199 USD

K-number	K111335
Device name	ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
Applicant	Tosoh Bioscience, Inc.
Product code	CKG
Device class	Class II
Decision date	Dec 1, 2011
Decision	Substantially Equivalent
Regulation	862.1025

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Source

View the full FDA submission: accessdata.fda.gov

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ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321

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