Name: Predicase
Price: 199 USD

K-number	K233663
Device name	N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Applicant	Siemens Healthcare Diagnostics Products GmbH
Product code	CFN
Device class	Class II
Decision date	Dec 13, 2023
Decision	Substantially Equivalent
Regulation	866.5510

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 →

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

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