Name: Predicase
Price: 199 USD

K-number	K921012
Device name	PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	LCX
Device class	Class II
Decision date	Apr 8, 1992
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 →

PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG

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