Name: Predicase
Price: 199 USD

K-number	K013899
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
Applicant	Ortho-Clinical Diagnostics
Product code	CDD
Device class	Class II
Decision date	Jan 24, 2002
Decision	Substantially Equivalent
Regulation	862.1810

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

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

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