K-number	K143296
Device name	AIA-PACK C-Peptide Control Set
Applicant	Tosoh Bioscience, Inc.
Product code	JJX
Device class	Class I
Decision date	Dec 16, 2014
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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AIA-PACK C-Peptide Control Set

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