Name: Predicase
Price: 199 USD

K-number	K223690
Device name	iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
Applicant	Shenzhen Yhlo Biotech Co., Ltd.
Product code	DHA
Device class	Class II
Decision date	Dec 11, 2023
Decision	Substantially Equivalent
Regulation	862.1155

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 →

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

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