Name: Predicase
Price: 199 USD

K-number	K132462
Device name	S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
Applicant	Hitachi Chemical Diagnostics, Inc.
Product code	CDN
Device class	Class II
Decision date	Oct 28, 2013
Decision	Substantially Equivalent
Regulation	862.1770

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Source

View the full FDA submission: accessdata.fda.gov

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S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE

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