Name: Predicase
Price: 199 USD

K-number	K042241
Device name	K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
Applicant	Kamiya Biomedical Co.
Product code	DGC
Device class	Class II
Decision date	Dec 10, 2004
Decision	Substantially Equivalent
Regulation	866.5510

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 →

K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C

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