FDA product code GOE: Antisera, Fluorescent, Poliovirus 1-3
GOE is the FDA product code for antisera, fluorescent, poliovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel. FDA has cleared 7 510(k) submissions under GOE, from 2 different applicants. The average 510(k) review took 608 days (median 616).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Poliovirus 1-3 |
| Device class | Class I |
| Regulation | 21 CFR 866.3405 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GOE clearance
Top GOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Light Diagnostics | 5 | 1995-09-12 |
| Chemicon Intl., Inc. | 2 | 1995-09-12 |
Most recent GOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940034 | Light Diagnostics | POLIOVIRUS 2 MONOCLONAL ANTIBODY | 1995-09-12 | 616 |
| K940026 | Light Diagnostics | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | 1995-09-12 | 617 |
| K940473 | Chemicon Intl., Inc. | ENTEROVIRUS 71 MONOCLONAL ANTIBODY | 1995-09-12 | 587 |
| K940017 | Light Diagnostics | POLIOVIRUS 3 MONOCLONAL ANTIBODY | 1995-09-12 | 616 |
| K940027 | Chemicon Intl., Inc. | ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES | 1995-09-12 | 617 |
Recalls for GOE devices
openFDA lists no recalls for product code GOE.
Frequently asked questions
What is FDA product code GOE?
GOE is the FDA product code for antisera, fluorescent, poliovirus 1-3. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel.
What device class is GOE?
Class I, regulation 21 CFR 866.3405. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GOE?
Across 7 cleared submissions the average was 608 days from receipt to decision (median 616).
Which companies have the most GOE clearances?
Light Diagnostics (5); Chemicon Intl., Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GOE
- Run a recall and safety report across every GOE manufacturer
- Watch product code GOE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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