Name: Predicase
Price: 199 USD

K-number	K854236
Device name	HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
Applicant	Nms Pharmaceuticals, Inc.
Product code	IAF
Device class	Class I
Decision date	Oct 10, 1986
Decision	Substantially Equivalent for Some Indications
Regulation	864.1850

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 →

HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS

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