meddevicedb.com FDA Device Reference

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)

DEN130010 Class II Post-NSE
Decision Date
2013-07-29
Sponsor / Applicant
Abbott Molecular, Inc.

Technical Specification

510(k) Submission ID DEN130010
Product Code PDO
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.1870
Decision Date 2013-07-29
Clearance Pathway Post-NSE

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

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) received FDA 510(k) clearance under submission number DEN130010, sponsored by Abbott Molecular, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2013-07-29.

Classification & Regulation

This clearance is catalogued under FDA product code PDO and 21 CFR 864.1870, within the Hematology review panel as a Class II device.