Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Test, Her-2/Neu, Monitoring

FDA product code NCW · 3 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6010
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2000-09-29 – 2003-01-30
↑