Name: Predicase
Price: 199 USD

K-number	K230741
Device name	Macro & Micro-Test HCG Pregnancy Test Midstream
Applicant	Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Oct 13, 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 →

Macro & Micro-Test HCG Pregnancy Test Midstream

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