Name: Predicase
Price: 199 USD

K-number	K052148
Device name	TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
Applicant	Reference Diagnostics, Inc.
Product code	JIT
Device class	Class II
Decision date	Nov 9, 2005
Decision	Substantially Equivalent
Regulation	862.1150

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 →

TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET

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