meddevicedb.com FDA Device Reference

DreaMed Advisor Pro

DEN170043 Class II Direct
Decision Date
2018-06-12
Sponsor / Applicant
DreaMed Diabetes, Ltd.

Technical Specification

510(k) Submission ID DEN170043
Product Code QCC
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1358
Decision Date 2018-06-12
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

DreaMed Advisor Pro received FDA 510(k) clearance under submission number DEN170043, sponsored by DreaMed Diabetes, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2018-06-12.

Classification & Regulation

This clearance is catalogued under FDA product code QCC and 21 CFR 862.1358, within the Clinical Chemistry review panel as a Class II device.