Name: Predicase
Price: 199 USD

K-number	K992800
Device name	SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
Applicant	Sigma Diagnostics, Inc.
Product code	CDQ
Device class	Class II
Decision date	Sep 28, 1999
Decision	Substantially Equivalent
Regulation	862.1770

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 →

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

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