K-number	K990258
Device name	QUANTECH TOTAL B-HCG ASSAY
Applicant	Quantech , Ltd.
Product code	NAL
Device class	Class II
Decision date	Dec 21, 1999
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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

QUANTECH TOTAL B-HCG ASSAY

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