meddevicedb.com FDA Device Reference

Technozym ADAMTS13 Activity

DEN230024 Class II Direct
Decision Date
2024-02-28
Sponsor / Applicant
Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM

Technical Specification

510(k) Submission ID DEN230024
Product Code SAC
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.7297
Decision Date 2024-02-28
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

Technozym ADAMTS13 Activity received FDA 510(k) clearance under submission number DEN230024, sponsored by Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2024-02-28.

Classification & Regulation

This clearance is catalogued under FDA product code SAC and 21 CFR 864.7297, within the Hematology review panel as a Class II device.