Name: Predicase
Price: 199 USD

K-number	K052819
Device name	VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	DEM
Device class	Class II
Decision date	Dec 23, 2005
Decision	Substantially Equivalent
Regulation	866.5130

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 CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III

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