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PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM

DEN140010 Class II Direct
Decision Date
2014-12-15
Sponsor / Applicant
Wallac OY

Technical Specification

510(k) Submission ID DEN140010
Product Code PJI
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.5930
Decision Date 2014-12-15
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM received FDA 510(k) clearance under submission number DEN140010, sponsored by Wallac OY. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2014-12-15.

Classification & Regulation

This clearance is catalogued under FDA product code PJI and 21 CFR 866.5930, within the Immunology review panel as a Class II device.