Name: Predicase
Price: 199 USD

K-number	K984321
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	CDD
Device class	Class II
Decision date	Jan 22, 1999
Decision	Substantially Equivalent
Regulation	862.1810

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS

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