Name: Predicase
Price: 199 USD

K-number	K091984
Device name	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
Applicant	Siemens Medical Solutions Diagnostics
Product code	DHB
Device class	Class II
Decision date	Oct 28, 2009
Decision	Substantially Equivalent
Regulation	866.5750

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 →

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

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