Name: Predicase
Price: 199 USD

K-number	K964842
Device name	IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
Applicant	Beckman Instruments, Inc.
Product code	CZW
Device class	Class II
Decision date	Jun 11, 1997
Decision	Substantially Equivalent
Regulation	866.5240

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 →

IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT

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