Name: Predicase
Price: 199 USD

K-number	K981444
Device name	BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
Applicant	Princeton BioMeditech Corp.
Product code	JHI
Device class	Class II
Decision date	Jul 22, 1998
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 →

BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP

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