GOE — Antisera, Fluorescent, Poliovirus 1-3 Class I
FDA product code GOE covers "Antisera, Fluorescent, Poliovirus 1-3", a Class I medical device regulated under 21 CFR 866.3405. Submissions are reviewed by the Microbiology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GOE
- Device Class
- Class I
- Regulation Number
- 866.3405
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K940027 | chemicon intl | ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES | September 12, 1995 |
| K940026 | light diagnostics | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | September 12, 1995 |
| K940017 | light diagnostics | POLIOVIRUS 3 MONOCLONAL ANTIBODY | September 12, 1995 |
| K940034 | light diagnostics | POLIOVIRUS 2 MONOCLONAL ANTIBODY | September 12, 1995 |
| K940473 | chemicon intl | ENTEROVIRUS 71 MONOCLONAL ANTIBODY | September 12, 1995 |
| K940018 | light diagnostics | POLIOVIRUS 1 MONOCLONAL ANTIBODY | September 8, 1995 |
| K940363 | light diagnostics | ENTEROVIRUS 70 MONCLONAL ANTIBODY | September 8, 1995 |