Name: Predicase
Price: 199 USD

K-number	K004038
Device name	TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
Applicant	Scantibodies Laboratory, Inc.
Product code	CEW
Device class	Class II
Decision date	Apr 30, 2001
Decision	Substantially Equivalent
Regulation	862.1545

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 PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600

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