Product code GOE— Microbiology
ENTEROVIRUS 70 MONCLONAL ANTIBODY
- Classification name
- Antisera, Fluorescent, Poliovirus 1-3
- Device class
- Class 1
- Regulation
- 21 CFR 866.3405
- Advisory panel
- Microbiology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code GOE
FDA has cleared devices under product code GOE, all in 1995, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code GOE
Recent clearances under product code GOE
- K940017 — POLIOVIRUS 3 MONOCLONAL ANTIBODY
- K940026 — POLIOVIRUS BLEND MONOCLONAL ANTIBODIES
- K940027 — ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
- K940034 — POLIOVIRUS 2 MONOCLONAL ANTIBODY
- K940473 — ENTEROVIRUS 71 MONOCLONAL ANTIBODY
- K940018 — POLIOVIRUS 1 MONOCLONAL ANTIBODY
- K940363 — ENTEROVIRUS 70 MONCLONAL ANTIBODY
Data sourced from openFDA. This site is unofficial and independent of the FDA.