Name: Predicase
Price: 199 USD

K-number	K220685
Device name	HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
Applicant	Qingdao Hightop Biotech Co., Ltd.
Product code	NFT
Device class	Class II
Decision date	May 5, 2022
Decision	Substantially Equivalent
Regulation	862.3100

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 →

HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx

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