Name: Predicase
Price: 199 USD

K-number	K151792
Device name	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JLW
Device class	Class II
Decision date	Nov 20, 2015
Decision	Substantially Equivalent
Regulation	862.1690

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 →

Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System

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