Name: Predicase
Price: 199 USD

K-number	K001266
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	CGN
Device class	Class II
Decision date	May 2, 2000
Decision	Substantially Equivalent
Regulation	862.1295

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

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