Name: Predicase
Price: 199 USD

K-number	K041748
Device name	AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
Applicant	Azog, Inc.
Product code	LCX
Device class	Class II
Decision date	Aug 9, 2004
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 →

AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)

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