Back to free search
Home / Search / K024193

MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS

Ortho-Clinical Diagnostics · Class II · Cleared Feb 21, 2003

K-numberK024193
Device nameMODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
ApplicantOrtho-Clinical Diagnostics
Product codeMMI
Device classClass II
Decision dateFeb 21, 2003
DecisionSubstantially Equivalent
Regulation862.1215
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 →

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

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →