Name: Predicase
Price: 199 USD

K-number	K201630
Device name	AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Applicant	Assure Tech. (Hangzhou) Co, Ltd.
Product code	DJG
Device class	Class II
Decision date	Aug 12, 2021
Decision	Substantially Equivalent
Regulation	862.3650

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 →

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

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