meddevicedb.com FDA Device Reference

DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)

DEN000008 Class II Post-NSE
Decision Date
2001-02-16
Sponsor / Applicant
Life Technologies, Inc.

Technical Specification

510(k) Submission ID DEN000008
Product Code NDS
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5885
Decision Date 2001-02-16
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

DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) received FDA 510(k) clearance under submission number DEN000008, sponsored by Life Technologies, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-02-16.

Classification & Regulation

This clearance is catalogued under FDA product code NDS and 21 CFR 876.5885, within the Gastroenterology, Urology review panel as a Class II device.